Accommodating intraocular lens

ABSTRACT

An intraocular lens (IOL) for implantation within a capsular bag of a patient&#39;s eye comprises an optical structure and a haptic structure. The optical structure comprises a planar member, a plano convex member, and a fluid optical element defined between the planar member and the plano convex member. The fluid optical element has an optical power. The haptic structure couples the planar member and the plano convex member together at a peripheral portion of the optical structure. The haptic structure comprises a fluid reservoir in fluid communication with the fluid optical element and a peripheral structure for interfacing to the lens capsule. Shape changes of the lens capsule cause one or more of volume or shape changes to the fluid optical element in correspondence to deformations in the planar member to modify the optical power of the fluid optical element.

CROSS-REFERENCE

This application is a continuation of PCT Application PCT/US14/26817,entitled “ACCOMMODATING INTRAOCULAR LENS,” filed Mar. 13, 2014, whichclaims the benefit of U.S. Provisional Application No. 61/881,870,entitled “ACCOMMODATING INTRAOCULAR LENS,” filed Sep. 24, 2013, and U.S.Provisional Application No. 61/828,651, entitled “ACCOMMODATINGINTRAOCULAR LENS,” filed May 29, 2013, and U.S. Provisional ApplicationNo. 61/785,711, entitled “ACCOMMODATING INTRAOCULAR LENS,” filed Apr.30, 2013, and U.S. Provisional Application No. 61/809,652, entitled“AIOL HIGH MOLECULAR WEIGHT REFRACTIVE INDEX MODIFIERS,” filed Apr. 8,2013, and U.S. Provisional Application No. 61/804,157, entitled “AIOLWITH CAPSULE FORMED HAPTIC,” filed Mar. 21, 2013. The presentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 14/181,145, entitled “HYDROPHILIC AIOL WITH BONDING,” filedFeb. 4, 2014, which is issued as U.S. Pat. No. 9,486,311 on Nov. 8,2016. The contents of each of the above references are incorporatedherein by reference in their entireties.

BACKGROUND

The present disclosure relates to medical devices and methods. Inparticular, the present disclosure relates to accommodating intraocularlenses (hereinafter “AIOLs”).

Cataracts can affect a large percentage of the worldwide adultpopulation with clouding of the native crystalline lens and resultingloss of vision. Patients with cataracts can be treated by native lensremoval and surgical implantation of a synthetic intraocular lens (IOL).Worldwide, there are millions of IOL implantation procedures performedannually. In the US, there are 3.5 million cataract proceduresperformed, while worldwide there are over 20 million annual proceduresperformed.

Although IOL implantation can effective at restoring vision, the priorIOLs provide less than ideal results in at least some instances. Manyprior IOLs are not able to change focus as a natural lens would (knownas accommodation). Also, the eyes receiving prior AIOLs can have atleast some refractive error after implantation, such that glasses can behelpful with distance vision. Although prior IOLs can be effective inproviding good far vision, patients in many cases need to wear glassesfor intermediate and near vision. Although prior Multi-focal IOLs thataddress this drawback have been proposed, the prior multi-focal IOLs canbe less than ideal. Although multi-focal IOLs generally perform well forreading and distance vision, in at least some instances priormulti-focal IOLs may cause significant glare, halos, and visualartifacts in at least some instances.

Although accommodating IOLs have been proposed to provide accommodativeoptical power in response to the distance at which a patient views anobject, the prior AIOLs can be less than ideal in at least somerespects. For example, prior AIOLs can provide less than ideal amountsof accommodation after implantation, and may provide less than idealrefractive correction of the eye. Also, the amount of accommodation ofthe prior AIOLs can decrease after implantation in at least someinstances. At least some of the prior AIOLs can be somewhat larger thanwould be ideal when inserted through an incision of the eye, and mayrequire the incision to be somewhat larger than would be ideal. Also,work in relation to embodiments suggests that at least some of the priorAIOLs can be somewhat less stable when placed in the eye than would beideal in at least some instances.

Improved implantable intraocular lenses that accommodate with thenatural focusing response of the eye that overcome at least some of theabove deficiencies would be desirable. Ideally, such improved AIOLswould provide increased amounts of accommodation when implanted, providerefractive stability, introduce few if any perceptible visual artifacts,and allow the optical power of the eye to change from far vision to nearvision in response to the distance of the object viewed by the patient.

SUMMARY

Embodiments of the present disclosure provide improved AIOL methods andapparatus. In many embodiments, the AIOL comprises an optical structurecomprising a stiff member and a deflectable member coupled to a hapticstructure, such that the stiff member and the deflectable membersubstantially define a chamber of the AIOL. The chamber of the AIOLcomprises a fluid having an index of refraction greater than the aqueoushumor of the eye, such that the deflectable member defines a convexlycurved surface of the chamber fluid in order to provide a fluid lenshaving adjustable optical power. The deflectable member and stiff memberare coupled to the haptic structure in order to deflect the profile ofthe deflectable member and fluid lens to a convexly curved profile whenthe eye accommodates for near vision. In many embodiments, the hapticstructure rotates relative to the stiff member in order to provide aninward force to the deflectable member when the capsular bag movesinward and the eye accommodates for near vision. The haptic structuremay comprise a curved capsular bag engaging portion shaped to receivethe capsular bag. The haptic structure can be coupled to the stiffmember at a first region, and to the deflectable member at a secondregion between the first region and the bag engaging portion, such thatthe forces of the capsular bag can be increased with leverage, in orderto provide increased amounts of inward force to the outer portions ofthe deformable member. In many embodiments, the deflectable member isconfigured to amplify movement inward movement of the outer portion ofthe deflectable member, such that an inner portion of the deflectablemember moves away from the stiff member more than the outer portion ofthe peripheral portion moves inward when the eye accommodates. Thisamplification of movement of the inner portion of the deflectable memberand corresponding increase in curvature coupled with leverage of thecapsular forces of the haptic can provide improved accommodation of theAIOL.

In many embodiments, the arrangement of the stiff member, thedeflectable member and the rotating haptic is capable of deflecting thedeflectable member with inward forces, such that decreased amounts offluid can be used with the AIOL and incision size decreased. In manyembodiments, the arrangement of the stiff member, the deflectable memberand the rotating haptic is capable of deflecting the deflectable memberwith inward forces without fluidic pressure of the lens chamber, and inat least some embodiments the arrangement can provide a convex curvatureto the deflectable member with negative pressure of the chamber. In manyembodiments, the chamber at least partially defined with the deflectablemember and the stiff member receives fluid from an outer portion of thechamber beneath the outer portion of the deflectable member, such thatthe amount of fluid contained in the AIOL and insertion profile can bedecreased.

The optical structure can be configured in one or more of many ways toprovide increased amounts of accommodation. The deflectable member maycomprise an inner optically corrective portion and an outer extensionportion to provide a curvature transition between the inner opticalportion and the haptic. The oppositely curved outer portion can decreasethe diameter of the optically corrective portion in order to theconcentrate optical power change within the inner portion. When the eyeaccommodates for near vision, the inner portion comprises an outerconvexly curved surface to provide optical power with the fluid of thechamber, and the extension comprises a concave curvature, which isopposite the curvature of the inner portion. The oppositely curvedextension can decrease the size of the inner optical zone, such that theoptical power and curvature provided with the deflectable member areincreased. The outer surface of inner portion of the deflectable membercan be convexly curved, concavely curved, or substantially flat for farvision and comprises a more positive curvature when deflected to theaccommodation configuration for near vision. The outer surface of theouter portion can be concavely curved or substantially flat for farvision and comprises a more negative curvature when deflected to theaccommodation configuration for near vision. The inner surfaces of theinner and outer portions of the deflectable member can be similarlycurved. In many embodiments, the deflectable member comprises asubstantially uniform thickness. Alternatively, the outer portion maycomprise a decreased thickness relative to the inner portion, and maycomprise an outer surface having a concave profile to facilitate convexcurvature of the inner portion when inward force is applied with thehaptic. The outer portion can be sized such that at least a portion ofthe outer portion is covered with the pupil in order to inhibitaberrations when the inner portion comprises the convex curvature andthe outer portion comprises the concave curvature.

In many embodiments the stiff member comprises a lens such as a planoconvex lens having an optical power configured to treat far vision ofthe patient. When the eye accommodates, the deflectable portion providesadditional optical power for near vision. In many embodiments, thediameter of the lens of the stiff member corresponds to the diameter ofthe inner portion of the deflectable member, such that the diameter ofthe lens of the stiff member is sized smaller than the outer portion ofthe deflectable member, in order to decrease the thickness profile ofthe AIOL when inserted into the eye.

In many embodiments, an accommodating IOL comprises a first lenscomponent and a second lens component each composed of a polymer, andadhesive comprising the polymer. Alternatively or in combination, thefirst component can be affixed to the second component with mechanicalcoupling such as interlocking joints, threads, mounts or fasteners. Inmany embodiments, the polymer can be hydrated and swells with hydration,such that the first component, the second component, and the adhesiveswell together (e.g., at the same or substantially similar rate). Byswelling together, stresses among the first component, the secondcomponent, and the adhesive can be inhibited substantially. Also, thehydratable adhesive allows the first and second components to bemachined in a stiff less than fully hydrated configuration prior toadhering of the components together. The stiff configuration maycomprise a less than fully hydrated polymer, such as a substantially drypolymer. The components can be bonded together in the stiffsubstantially configuration to facilitate handling during manufacturing,and subsequently hydrated such that the components bonded the adhesivecomprise a soft hydrated configuration for insertion into the eye. Theadhesive comprising the polymer can bond the first and second lenscomponents together with chemical bonds similar to the polymer materialitself in order to provide increased strength.

In a first aspect, an intraocular lens comprises an optical structurehaving an optical power and a haptic structure. The optical structurecomprises a deflectable member, a stiff member, and a fluidic chamberdefined at least partially with the stiff member and the deflectablemember. The haptic structure has an outer structure to engage a capsuleof the eye and an inner structure coupled to the deflectable member toincrease curvature of the deflectable member when the haptic structurerotates relative to the stiff member.

In many embodiments, the deflectable member is deflected from a firstprofile to a second profile, in which the second profile is more curvedthan the first profile. The chamber comprises a fluid having an index ofrefraction greater than 1.33, such that the chamber comprises a firstamount of optical power with the deflectable member in the firstconfiguration and a second amount of optical power with the deflectablemember in the second configuration, and the second amount of opticalpower is greater than the first amount.

In many embodiments, the deflectable structure comprises an inneroptical portion and an outer extension portion. The stiff member, thehaptic and the deflectable member can be arranged such that the inneroptical portion moves away from the stiff member with increasedcurvature and the outer extension moves toward the stiff member with anopposite curvature in order to provide increased optical power. Movementof the inner optical portion away from the stiff member and movement ofthe outer extension portion toward the stiff member can transmit fluidfrom an outer portion of the chamber beneath the outer extension portionto an inner portion of the chamber beneath the inner optical portion,such that fluid transfer is decreased and a volume of fluid of the AIOLcan be decreased.

In many embodiments, the rotation occurs about an axis extending througha perimeter of the haptic structure. When the intraocular lens is placedin the eye, the perimeter of the haptic structure may be on a planetransverse to the optical axis of the eye, for example.

In many embodiments, the haptic structure may comprise a cantileveredhaptic structure anchored on an inner end to the stiff member at a firstlocation. The haptic may comprise a length extending a distance from theinner end to an outer end. The haptic structure may comprise athickness, and the length may be greater than the thickness. Thedeflectable member may be coupled to the haptic structure at a secondlocation separated from the first location by a separation distance. Thelength may be greater than the separation distance in order to separatean inner optical portion the deflectable member from the stiff memberwhen the haptic structure rotates relative to the stiff member.

In many embodiments, the stiff member comprises one or more convexlycurved optical surfaces. The stiff member may extend to a thin portionlocated near an outer edge of the stiff member. The thin portion maydefine an anchoring pivot structure around which the haptic structurerotates in order to urge the deflectable member inward with radial forcewhen the haptic rotates in response to pressure of the structure of theeye.

In many embodiments, the deflectable member comprises an inner opticalportion and an outer resilient extension coupled to the hapticstructure. The resilient extension may comprise a thickness less than athickness of the inner region of the deflectable member. The resilientextension may comprise a curvature opposite a curvature of the inneroptical region when the resilient extension has separated the inneroptical portion of the deflectable member away from the stiff member.The inner edge of the haptic structure may exert a radial force on theresilient extension of the deformable member to one or more of decreasea diameter of the inner optical region, or to deflect curvature of theresilient extension and the inner optical region in opposite directionsrelative to one another in order to urge the inner optical region awayfrom the stiff member with spherical deflection of the inner opticalregion and urge the extension toward the stiff member in response torotation of the haptic structure relative to the stiff member.

In many embodiments, a decrease in diameter of the deflectable membercomprises a transition from a first diameter to a second diameter lessthan the first diameter in response to rotation of the haptic structure,wherein the decrease in diameter spherically deflects the inner opticalportion away from the stiff member and changes a shape of thefluid-filled chamber to a more convexly curved profile in order toincrease the optical power of the optical structure.

In many embodiments, the convexly curved profile of the fluid-filledchamber comprises an increased volume in order to change the opticalpower of the optical structure. Fluid may be drawn into the chamber froma peripheral reservoir in response to the increased volume.

In many embodiments, the haptic structure moves a peripheral portion ofthe deflectable member radially inward a first distance in response tothe radial force directed thereon and the inner region of the deformablemember may be urged away from the stiff member a second distance greaterthan the first distance in response to the rotation of the hapticstructure so as to provide amplification of the second movement relativeto the first movement and shape the deflectable member with a sphericalprofile. The deflectable member may comprise a substantially uniform andconstant thickness to inhibit distortion.

In another aspect of the disclosure, a method of providing accommodationto an eye of the patient comprises placing an intraocular lens within alens capsule of the eye. The intraocular lens may have an opticalstructure and a haptic structure coupled to the optical structure at anouter region of the optical structure. The optical power of an opticalstructure of the intraocular lens may be changed by rotating the hapticstructure at the outer region in response to an inward force of the lenscapsule.

In many embodiments, the haptic structure is rotated about an axisextending through a perimeter of the haptic structure. When theintraocular lens is placed in the eye, the perimeter of the hapticstructure may be on a plane transverse to the optical axis of the eye,for example. In many embodiments, the method may further includeanteriorly translating the at least a portion of the optical structurerelative to an outer edge of the haptic structure in response to therotation of the haptic structure. The translation of the at least aportion of the optical structure may change an optical power of the eye.

In many embodiments, the at least a portion of the optical structure maycomprise a deflectable profile member comprising an outer region coupledto the inner edge of the haptic structure, an inner region, and apivoting region between the haptic structure and the inner region. Theinner edge of the haptic structure may exert an inward force on theouter region of the deflectable member to one or more of: decrease adiameter thereof; or pivot the outer and inner regions relative to oneanother at the pivoting region to deflect the inner region away from thestiff member in response to the rotation of the haptic structure tochange the haptic power. The decrease in diameter of the deflectablemember and the pivoting of the outer and inner regions of thedeflectable member relative to one another may change one or more of ashape or a volume of the fluid-filled chamber to change the opticalpower of the optical structure. The inner edge of the haptic may move afirst distance relative to the inner edge in response to the radialforce directed on the inner edge; and the inner region of thedeflectable member may be deflected away from the stiff member a seconddistance greater than the first distance in response to the rotation ofthe haptic structure.

In another aspect of the disclosure, an intraocular lens is provided.The intraocular lens may comprise an optical structure having an opticalpower and comprising a deflectable member, a stiff member, and a fluidchamber defined at least partially between the deflectable member andthe stiff member. The intraocular lens may comprise a haptic structurecoupled to a peripheral region of the stiff member and comprising afirst exterior element, a second exterior element, and a fluid reservoirdefined at least partially between the first exterior element and thesecond exterior element. The fluid reservoir may be in fluidcommunication with the fluid chamber with one or more channels. Thehaptic structure may be configured to rotate at the peripheral regionand the second exterior element may be configured to deflect inwardtoward the first exterior element to decrease a volume of the fluidreservoir in response to an inward force of a lens capsule in order tochange the optical power. In many embodiments, the haptic structure isconfigured to rotate about an axis extending through a perimeter of thehaptic structure. When the intraocular lens is placed in the eye, theperimeter of the haptic structure may be on a plane transverse to theoptical axis of the eye, for example. In many embodiments, the secondexterior element may have an outer region, an inner region, and apivoting region between the outer region and the inner region. The outerand inner regions of the second exterior element may pivot relative toone another at the pivoting region to deflect the second exteriorelement toward the first exterior element. In many embodiments, a volumeof the fluid chamber may increase in response to the decrease in thevolume of the fluid reservoir to change the optical power. A shape ofthe fluid-filled chamber may change in response to the increase in thevolume of the lens fluid chamber to change the optical power. The shapechange of the fluid-filled chamber may comprise a deflection of an innerregion of the deflectable member away from the stiff member and adecrease in a radius of curvature of the deflectable member. In manyembodiments, an inner edge of the haptic structure may move a firstdistance in response to the rotation of the haptic structure and theinner region of the deflectable member may be deflected away from thestiff member a second distance greater than the first distance to changethe optical power. The shape change of the fluid chamber may leave thegeometry of the stiff member substantially undeflected.

In many embodiments, the deflectable member may comprise an outer regioncoupled to the inner edge of the haptic structure, an inner region, anda pivoting region between the outer and inner regions. The inner edge ofthe haptic structure may exert an inward force on the outer region ofthe deflectable member to one or more of: change a diameter thereof; orpivot the outer and inner regions relative to one another at thepivoting region to deflect the inner region away from the stiff memberin response to the rotation of the haptic structure to change theoptical power of the optical structure. The deflectable member and thestiff member may be supported with the haptic structure and maytranslate together in a first direction in response to the rotation ofthe outer end of the haptic structure in a second direction opposite thefirst direction. The deflectable member may be located on a posteriorportion of the optical structure and the stiff member may be located onan anterior portion of the optical structure of the eye. The deflectablemember may move posteriorly relative to the stiff member to increasecurvature of the deflectable member when the haptic structure rotates inresponse to the inward force of the lens capsule. The haptic structuremay translate the stiff member and the deflectable member anteriorlytogether such that the optical power of the eye is increased with eachof the increased curvature of the deflectable member, deflection of thedeflectable member posteriorly relative to the stiff member, andanterior translation of the stiff member and the deflectable member.

This aspect of the disclosure may also provide a method of providingaccommodation to a patient's eye, such as by providing and using theintraocular lens provided.

In another aspect of the disclosure, a method is provided for providingaccommodation to an eye of the patient. The method may comprise placingan intraocular lens within a lens capsule of the eye. A haptic structureof the intraocular lens at a peripheral portion of an optical structureof the intraocular lens may be rotated in response to an inward force ofthe lens capsule. The rotation may occur about an axis extending througha perimeter of the haptic structure. A member of the optical structuremay be deflected to a more curved profile in response to the rotation tochange an optical power of the eye. A shape and a volume of a fluidchamber of the optical structure may be changed in response to therotation to change the optical power. The shape and volume of the fluidchamber may be changed by deflection one or more of an anterior orposterior member of the optical structure to increase a radius ofcurvature. The optical structure may be translated in an anteriordirection relative to an outer edge of the haptic structure in responseto the rotation to change the optical power. In many embodiments, thecombination of such separation, deflection, and translation may combineto change the optical power.

In yet another aspect of the disclosure, a method of providingaccommodation to an eye of the patient is provided. The method maycomprise placing an intraocular lens within a lens capsule of the eye.The intraocular lens may comprise an optical structure and a hapticstructure coupled to a peripheral region of the optical structure. Anoptical power of an optical structure of the intraocular lens may bechanged be rotating a haptic structure of the intraocular lens at theperipheral region to decrease a volume of a fluid reservoir of thehaptic structure in response to an inward force of the lens capsule. Therotation of the haptic structure of the intraocular lens may occur aboutan axis extending through a perimeter of the haptic structure. When theintraocular lens is placed in the eye, the perimeter of the hapticstructure may be on a plane transverse to the optical axis of the eye,for example. The fluid reservoir of the haptic structure may be definedat least partially between first and second exterior members of thehaptic structure. The volume of the fluid reservoir may be decreased bydeflecting the second exterior member inward toward the first exteriormember in response to the inward force. Changing the optical power ofthe optical structure may further comprise increasing a volume of afluid chamber of an optical structure in response to the decrease in thevolume of the fluid reservoir. Changing the optical power of the opticalstructure may further comprise changing a shape of the fluid-filledchamber in response to the increased volume of the fluid-filled chamber.

In many embodiments, changing the shape of the fluid-filled chambercomprises a deflection of an inner region of a deflectable member of theoptical structure away from a stiff member and a decrease in a radius ofcurvature of the deflectable member toward the stiff member. The shapeof the fluid-filled chamber may further by changed by translating theinner region and an outer region of the deflectable member away from thestiff member. An inner edge of the haptic structure may move a firstdistance in response to the rotating of the haptic structure. The innerregion of the deflectable member may be deflected away from the stiffmember a second distance greater than the first distance to change theoptical power. The shape change of the fluid-filled chamber may leavethe geometry of the stiff member substantially undeformed. Thedeflectable member of the optical structure may be located on aposterior portion of the optical structure and the stiff member may belocated on an anterior portion of the optical structure when placed inthe eye. Changing the optical power of the optical structure maycomprise moving the deflectable member anteriorly relative to the stiffmember to increase curvature of the deflectable member when the hapticstructure rotates in response to the inward force of the lens capsule toincrease the optical power of the eye. The stiff member and thedeflectable member may be translated anteriorly together with the hapticstructure to increase the optical power of the eye. The perimeter of thedeflectable member may be separated away from the perimeter of the stiffmember to increase the optical power of the eye. In many embodiments,such deflection, translation, and separation can be used in combinationto increase the optical power of the eye.

In another aspect of the disclosure, an intraocular lens comprises anoptical structure comprising a posterior member, an anterior member, anda fluid-filled chamber between the posterior and anterior members. Theintraocular lens may include a haptic structure interlocking peripheralregions of the posterior and anterior members to inhibit leakage of afluid into and out of the fluid-filled haptic chamber. In manyembodiments, the interlocking regions may comprise a fluid tight seal toinhibit leakage of the fluid. The haptic structure may have a first sidehaving one or more male members and a second side having on or morefemale members. The one or more male members may pass through theperipheral regions of the posterior and anterior members to be receivedby the one or more female members to interlock the peripheral regions.The peripheral regions of the posterior and anterior members may haveone or more aperture through which the one or more members pass through.The peripheral regions of one or more of the posterior or anteriormembers may have one or more male members to be received by one or morefemale members of the haptic structure to interlock the peripheralregions. The interlocking of the peripheral regions of the posterior andanterior members by the haptic structure may be maintained as theintraocular lens is one or more of: deformed to change an optical powerof the optical structure; or, folded or rolled into a deliveryconfiguration.

In yet another aspect of the disclosure, an intraocular lens isprovided. The intraocular lens comprises an optical structure comprisinga posterior member, an anterior member, and a fluid-filled chamberbetween the posterior and anterior members providing an optical power.The intraocular lens may comprise a haptic structure coupled to theoptical structure. One or more of a shape or volume of the fluid-filledchamber may be configured to change in response to a radial forceexerted on the haptic structure. The change of one or more of the shapeor volume of the fluid-filled chamber may change the optical power ofthe fluid-filled chamber while leaving optical powers provided by theposterior and anterior members substantially unchanged.

In another aspect of the disclosure, a method of providing accommodationto an eye of the patient is provided. The method may comprise placing anintraocular lens within a lens capsule of the eye. One or more of ashape or volume of a fluid-filled chamber of the intraocular lens may bechanged to change an optical power of the fluid-filled chamber whileleaving optical powers provided by the posterior and anterior memberssubstantially unchanged.

In yet another aspect of the disclosure, an intraocular lens isprovided. The intraocular lens may comprise an optical structure forplacement in an eye.

In another aspect of the disclosure, a method is provided. The methodmay comprise placing an optical structure in an eye.

In many embodiments, the deflectable optical members as described hereinhave the advantage of deflecting while substantially maintaining athickness of the optical member in order to inhibit optical aberrationswhen the member deflects.

An aspect of the disclosure provides an intraocular lens forimplantation within a lens capsule of a patient's eye. The intraocularlens may comprise an optical structure and a haptic structure. Theoptical structure may have a peripheral portion and may comprise aplanar member, a plano convex member coupled to the planar member at theperipheral portion, and a fluid optical element defined between theplanar member and the plano convex member. The fluid optical element maycomprise a fluid having a refractive index similar to either or both thematerials comprising the planar member and the plano convex member. Thehaptic structure may couple the planar member and the plano convexmember at the peripheral portion of the optical structure. The hapticstructure may comprise a fluid reservoir in fluid communication with thefluid optical element and a peripheral structure for interfacing to thelens capsule. Shape changes of the lens capsule may cause one or more ofvolume or shape changes to the fluid optical element in correspondenceto deformations of the planar member to modify the optical power of thefluid optical element. For example, shape changes of the lens capsulemay cause the haptic structure to exert a mechanical force on the planarmember to deform the member and correspondingly modify the optical powerof the fluid optical element. Such deformations of the planar member mayin some cases cause no change to the optical power of the planar member,the plano convex member, or both (i.e., the change in optical power maysolely be provided by one or more of the shape or volume changes to thefluid optical element and optionally changes to the anterior-posteriorposition of the intraocular lens within the lens capsule.)

The haptic peripheral structure may be stiffly coupled to thesubstantially planar member of the optical structure such that aradially directed force on the haptic peripheral structure may deflectthe substantially planar member away from the plano convex member inorder to modify the optical power of the fluid optical element. Theplanar member may be anchored to a structure along a circular peripheralportion of the planar member. Deflection of the planar member away fromthe plano convex member may provide a spherical optical correction. Thechange in optical power of the fluid optical element may comprise aresponse to a transfer of fluid into or out of the fluid optical elementfrom the fluid reservoir of the haptic structure.

A force imposed on the haptic fluid reservoir may deform the hapticfluid reservoir to modify the optical power of the fluid opticalelement. The force imposed on the haptic fluid reservoir may cause fluidto transfer into or out of the fluid optical element from the hapticfluid reservoir to reversibly deform the haptic fluid reservoir.

In many embodiments, wherein volume changes to the fluid optical elementare provided by a fluid of the haptic fluid reservoir. In manyembodiments, fluid transfer into or out of the fluid optical elementleaves the plano convex member undeformed. The plano convex member maycomprise a stiff member and the planar member may comprise a deflectablemember. In these embodiments, the fluid optical element may provide amajority of the optical power of the intraocular lens. Fluid within thefluid optical element and within the fluid reservoir of the hapticstructure may have a refractive index of greater than or equal to 1.33.

The fluid within the fluid optical element and the fluid reservoir ofthe haptic structure may comprise oil such as a silicone oil or asolution such as a high molecular weight dextran. The fluid can beprovided with a suitable index of refraction. The high molecular weightdextran configured with a suitable index of refraction greater than 1.33and an osmolality similar to the aqueous humor of the eye. The highmolecular weight dextran may have a mean molecular weight of at least 40kDa, and the mean molecular weight can be within a range from about 40kDa to about 2000 kDa, with intermediate ranges having upper and lowervalues defined with any of 40 kDa, 70 kDa, 100 kDa, 1000 kDa, or 2000kDa. The high molecular weight dextran may comprise a distribution ofmolecular weights, and the distribution of molecular weights can benarrow or broad. As the index of refraction can be determined based onthe weight of dextran per volume and the osmolality by the number ofsolute particles per volume, the mean molecular weight and amount ofdextran can be used to configure the dextran solution with theappropriate index of refraction and osmolality.

In many embodiments, the haptic structure is configured to orient theintraocular lens in place within the lens capsule of the patient's eye.In many embodiments, the haptic structure comprises an anterior hapticstructure and a posterior haptic structure, and the anterior hapticstructure and the posterior structure are coupled together to define thefluid reservoir therebetween. In many embodiments, the haptic structurecomprises an annular structure coupled to the peripheral region of theoptical structure. The haptic structure may comprise a plurality of tabstructures coupled to and distributed over the peripheral portion of theoptical structure.

The peripheral portion may comprise a plurality of apertures and thehaptic structure may be coupled to the peripheral portion through theplurality of apertures. The plurality of apertures may be orientedsubstantially parallel to the optical axis of the intraocular lens.Alternatively or in combination, the plurality of apertures may beoriented transverse to the optical axis of the intraocular lens. Thehaptic structure may comprise one or more posts or other structures forplacement through the plurality of apertures of the peripheral portionof the optical structure to couple the haptic structure to theperipheral portion. Alternatively or in combination, the opticalstructure may comprise posts for mating with structures such asapertures in the haptic structures.

The intraocular lens may be sufficiently flexible to be folded into areduced cross-section delivery configuration. The reduced cross-sectiondelivery configuration of the intraocular lens may be attained byfolding or rolling the intraocular lens around a delivery axis normal toan optical axis of the lens. Alternatively or in combination, thereduced cross-section delivery configuration of the intraocular lens maybe attained by advancing the intraocular lens through a delivery tube oraperture.

In many embodiments, the planar member is posterior of the plano convexmember when the intraocular lens is placed in the lens capsule.

Another aspect of the disclosure provides a method of providingaccommodation in an eye of a patient. First, an intraocular lens may beprovided. The provided intraocular lens may comprise an opticalstructure having a peripheral portion and a haptic structure. Theoptical structure may comprise a planar member, a plano convex membercoupled to the planar member at the peripheral portion, and a fluidoptical element defined between the planar and plano convex members. Thefluid optical element may comprise a fluid having a refractive indexsimilar to either or both the materials comprising the between theplanar and plano convex members. The fluid optical element may have anoptical power. The haptic structure may couples the planar and planoconvex members together at the peripheral portion of the opticalstructure. The haptic structure may comprise a fluid reservoir in fluidcommunication with the fluid optical element and a peripheral structurefor interfacing to the lens capsule. Second, the intraocular lens may befolded into a reduced profile configuration. Third, the foldedintraocular lens is implanted into a lens capsule of the patient's eye.The folded intraocular lens reverts into a working configuration fromthe reduced profile configuration when implanted into the lens capsule.Fourth, one or more of the optical structure or the haptic structure maybe actuated to cause one or more of volume or shape changes to the fluidoptical element in correspondence to deformations in the planar memberto modify the optical power of the fluid optical element.

One or more of the optical or haptic structure may be actuated byradially directing a force on the haptic structure to deform the planarmember to modify the optical power of the fluid optical element. Thehaptic peripheral structure may be stiffly coupled to the substantiallyplanar member of the optical structure. The change in optical power ofthe fluid optical element may be accompanied by a transfer of fluid intoor out of the fluid optical element from the fluid reservoir of thehaptic structure. Transfer of fluid into or out of the fluid opticalelement from the haptic fluid chamber may deflect the planar memberwhile leaving the plano convex member undeflected. In alternativeembodiments, transfer of fluid into or out of the fluid optical elementfrom the haptic fluid chamber may deflect the planar member andoptionally also the plano convex member.

Actuating one or more of the optical structure and the haptic structuremay be actuated by imposing a force on the haptic fluid reservoir toreversibly deform the haptic fluid reservoir to modify the optical powerof the fluid optical element.

In many embodiments, the peripheral portion of the optical structurecomprises a plurality of apertures and the haptic structure couples theposterior and anterior members together at the peripheral portion of theoptical structure through the plurality of apertures. The hapticstructure coupled to the plurality of apertures of the peripheralportion may maintain the substantially planar and plano convex memberscoupled together as the intraocular lens is folded and during functionor operation of the intraocular lens. The plurality of apertures may beoriented substantially parallel to the optical axis of the intraocularlens. The plurality of apertures may be oriented transverse to theoptical axis of the intraocular lens. The haptic structure may compriseone or more posts for placement through the plurality of apertures tocouple the haptic structure to the peripheral region. Alternatively orin combination, the peripheral portion of the optical structure may haveone or more apertures through which one or more posts of the hapticstructure can pass through to couple the optical and haptic structurestogether.

The intraocular lens may be folded into the reduced profileconfiguration by folding or rolling the intraocular lens around adelivery axis normal to an optical axis of the lens. Alternatively or incombination, the intraocular lens may be folded into the reduced profileconfiguration by advancing the intraocular lens through a delivery tubeor aperture.

The folded intraocular lens may be implanted into the lens capsule byallowing the fluid within the lens fluid chamber to reach an osmoticequilibrium with fluid present in the lens capsule. One or more of theplanar or plano convex members may be water permeable to allow theosmotic equilibrium to be reached. In many embodiments, the porousposterior or anterior member is non-permeable to compounds having amolecular weight of greater than 40 kDa.

In many embodiments, one or more of the planar or plano convex membershas substantially no optical power.

In many embodiments, the planar member is posterior of the plano convexmember when the intraocular lens is placed in the lens capsule.

In another aspect, embodiments provide a method of manufacturing anaccommodating intraocular lens. A first lens component comprising apolymer is provided. A second lens component comprising the polymer isprovided. The first lens component is boned to the second lens componentwith an adhesive. The adhesive may comprise a prepolymer of the polymer.

In many embodiments, the prepolymer is cured to bond the first lenscomponent to the second lens component with the polymer extendingbetween the first lens component and the second lens component.

In many embodiments, the first lens component and the second lenscomponent each comprise a stiff configuration when the first lenscomponent is bonded to the second lens component with the polymerextending between the first component and the second component.

In many embodiments, the first lens component is hydrated, the secondlens component and the cured adhesive to provide a hydrated, softaccommodating intraocular lens.

In many embodiments, hydrating the first lens component, the second lenscomponent and the adhesive comprises fully hydrating the polymer of eachof the components and the adhesive to an amount of hydrationcorresponding to an amount of hydration of the polymer when implanted.

In many embodiments, each of the first lens component, the second lenscomponent and the cured adhesive each comprise a stiff configurationprior to hydration and soft configuration when hydrated and wherein eachof the first lens component, the second lens component and the curedadhesive expand a substantially similar amount from the firstconfiguration to the second configuration in order to inhibit stress atinterfaces between the adhesive and the first and second components.

Many embodiments further comprise providing the polymer material andshaping the first lens component and the second lens component from thepolymer material.

In many embodiments, the first lens component and the second lenscomponent are each turned on a lathe when stiff in order to shape thefirst lens component and the second lens component.

In many embodiments, the first lens component and the second lenscomponent are molded.

In many embodiments, the prepolymer comprises one or more of a monomer,an oligomer, a partially cured monomer, particles, or nano particles ofthe polymer.

In many embodiments, the first lens component comprises a disc shapedstructure and the second component comprises a disc shaped structure andwherein the first component and the second component define a chamberwith the disc shaped structures on opposite sides of the chamber whenbonded together.

In many embodiments, one or more of the first component or the secondcomponent comprises a groove sized and shaped to receive the oppositecomponent and wherein the adhesive is placed on the groove.

In many embodiments, one or more of the first component or the secondcomponent comprises an annular structure extending between the discstructure and the second disc structure in order to separate the firstdisc structure from the second disc structure and define a side wall ofthe chamber.

In another aspect, an accommodating intraocular lens comprises a firstlens component, a second lens component and an adhesive. The first lenscomponent comprises a polymer material. The second lens componentcomprises the polymer material. A cured adhesive comprises the polymerbetween at least a portion of the first component and the secondcomponent in order to bond the first lens component to the second lenscomponent and define a chamber.

In many embodiments, the chamber comprises an optical element.

Many embodiments further comprise a fluid within the chamber having anindex of refraction greater than an index of refraction of an aqueoushumor of an eye of about 1.336 and wherein one or more of the firstcomponent or the second component is configured to deform to increase anoptical power of the accommodating intraocular lens.

Many embodiments further comprise one or more haptics to engage a wallof a capsular bag of the eye and increase curvature of one or more ofthe first lens component or the second lens component in response to thewall of the capsular bag contracting in order to increase optical powerof the accommodating intraocular lens.

Many embodiments further comprise a fluid, the fluid comprising one ormore of a solution, an oil, a silicone, oil, a solution of highmolecular weight molecules or high molecular weight dextran.

Many embodiments further comprise a seam comprising the adhesive, theseam extending circumferentially along the at least a portion of thefirst component and the second component.

In many embodiments, the first lens component comprises a first discshaped structure and the second lens component comprises a second discshaped structure on opposite sides of the chamber and wherein an annularstructure extends between the first disc shaped structure and the seconddisc shaped structure to separate the first disc shaped structure fromthe second disc shaped structure and define the chamber.

In many embodiments, the intraocular lens comprises a stiffconfiguration prior to implantation and a soft configuration whenimplanted.

In many embodiments, the first lens component comprises a first discshaped optical structure comprising one or more of a lens, a meniscus, ameniscus lens, a flat plate, a flat and wherein the second lenscomponent comprises a second disc shaped optical structure comprisingone or more of a lens, a meniscus, a meniscus lens, a flat plate, or aflat plate.

Yet another aspect of the disclosure provides an intraocular lens forimplantation within a lens capsule of a patient's eye. The intraocularlens may comprise an optical structure and a haptic structure. Theoptical structure may have a peripheral portion and may comprise aposterior member, an anterior member coupled to the posterior member atthe peripheral portion, and a fluid optical element defined between theposterior and anterior members. The fluid optical element may comprise afluid having a refractive index similar to either or both the materialscomprising the posterior member and the anterior member. The fluidoptical element may have an optical power. The haptic structure maycouple the posterior and anterior members at the peripheral portion ofthe optical structure. The haptic structure may comprise a fluidreservoir in fluid communication with the fluid optical element and aperipheral structure for interfacing to the lens capsule. Shape changesof the lens capsule may cause one or more of volume or shape changes tothe fluid optical element in correspondence to deformations in one ormore of the posterior or anterior members to modify the optical power ofthe fluid optical element. One or more of the posterior member or theanterior member of the optical structure may be permeable to water suchthat water present in the lens capsule of the patient's eye may becapable of transferring into or out of the fluid lens chambertherethrough to achieve an osmotic equilibrium with fluid present in thelens capsule when the intraocular lens is placed therein. The variousfeatures of the intraocular lens may further be configured in many waysin accordance with the many embodiments disclosed herein.

In another aspect of the disclosure, an implantable intraocular lens isprovided. The intraocular lens may comprise an optical structure havinga fluid chamber and a material within the fluid chamber. The materialmay comprise a less than fully hydrated state. A portion of the opticalstructure may be configured to provide water to the fluid chamber andinhibit leakage of the material from the fluid chamber in order to fullyhydrate the material and expand the fluid chamber when placed in theeye.

In yet another aspect of the disclosure, a method of implanting anartificial lens within a lens capsule of a patient's eye is provided.The method may comprise advancing an intraocular lens comprising a lessthan fully hydrated configuration through an incision of the eye. Waterfrom the lens capsule may pass through at least a portion of the opticalstructure to fully hydrate the intraocular lens. In many embodiments,material within a fluid chamber of an optical structure of intraocularlens may be inhibited from leakage from the at least a portion of theoptical structure while water from the lens capsule passes through tofully hydrate the material.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the disclosure are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present disclosure will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the disclosure are utilized, andthe accompanying drawings of which:

FIG. 1 illustrates an accommodating intraocular lens system, inaccordance with many embodiments;

FIG. 2 illustrates a side view of a lens support structure and lens, inaccordance with many embodiments;

FIG. 3 illustrates a sectioned view of a lens support structureincorporating a lens interface using threads, in accordance with manyembodiments;

FIG. 4 illustrates a sectioned view of a lens support structureincorporating a lens interfaced using an interference fit, in accordancewith many embodiments;

FIG. 5 illustrates an AIOL in which half of the support structure andhaptic structures are comprised in an upper and lower half of the AIOLand all fabricated from the same material, in accordance with manyembodiments;

FIG. 6 illustrates an AIOL wherein the haptic and support structures areintegral and are configured as a toroid like structure, in accordancewith many embodiments;

FIG. 7 illustrates a variation of the AIOL of FIG. 6 which incorporatesfeatures which help to reduce the delivery cross section, in accordancewith many embodiments;

FIG. 8 illustrates an AIOL which comprises an elastomeric supportstructure filled with a fluid capable of being hardened after deliveryof the AIOL, in accordance with many embodiments;

FIGS. 9A, 9B, and 9C depict alternate collapsible lens supportstructures, in accordance with many embodiments;

FIGS. 10 through 14B illustrate alternate AIOL structures where an AIOLis inserted into and interfaced to the natural capsule such that theattachment zones seal a semi toroidal region of capsule, and where fluidtransfer between the semi toroidal region and the interior of the AIOLcauses an accommodation change in the AIOL, in accordance with manyembodiments;

FIG. 10 depicts an AIOL with alternate haptic structures where a fluidchamber is formed by sealing the equatorial and posterior regions of thelens capsule incorporating one optical element, in accordance with manyembodiments;

FIG. 11 depicts an AIOL with alternate haptic structures where a fluidchamber is formed by sealing the equatorial and posterior regions of thelens capsule incorporating two optical element, in accordance with manyembodiments;

FIG. 12 depicts an AIOL with alternate haptic structures where a fluidchamber is formed by a thin membrane sealing the equatorial andposterior regions of the lens capsule incorporating two optical element;in accordance with many embodiments;

FIG. 13 depicts an AIOL with alternate haptic structures where a fluidchamber is formed by a thin membrane and by sealing the equatorial andposterior regions of the lens capsule incorporating one optical element,in accordance with many embodiments;

FIG. 14A illustrates an alternate embodiment after implantation of theAIOL and FIG. 14B illustrates the installed AIOL, post surgery, wherethe lens capsule has conformed to the installed device, in accordancewith many embodiments;

FIG. 15 depicts an optical structure comprising an anterior andposterior surface, in accordance with many embodiments;

FIG. 16A illustrates a lens support structure joined to an opticalstructure prior to bonding and FIG. 16B represents a final AIOL withpoints bonded together providing a seal along the perimeter, inaccordance with many embodiments;

FIG. 17 represents the addition of alternate posterior opacificationcell dam and anterior capsulorhexis support to the AIOL of FIG. 16B, inaccordance with many embodiments;

FIG. 18 depicts an alternate AIOL, in accordance with many embodiments;

FIG. 19 depicts an alternate optical structure, in accordance with manyembodiments;

FIG. 20 is a top sectional view of an AIOL incorporating the opticalassembly depicted in FIG. 19;

FIG. 21A is a lateral sectional view of the AIOL of FIG. 20;

FIG. 21B is a modeled view of the haptic structure of FIGS. 20-22 underradial and pressure loading associated with forces generated by acapsular structure of the eye, in accordance with many embodiments

FIG. 22 is a view of a final AIOL assembly comprised of elementsdepicted in FIGS. 19-21, in accordance with many embodiments;

FIGS. 23A and 23B illustrate an alternate AIOL embodiment and method ofmanufacture, in accordance with many embodiments;

FIG. 24 depicts an alternate low-profile AIOL with alternate haptics andsupport structure, in accordance with many embodiments;

FIG. 25A is a model of the accommodation potential an AIOL similar thatthat of FIG. 24, in accordance with many embodiments;

FIGS. 25B and 25C show perspective sectional views of the AIOL of FIG.25A;

FIG. 26 shows a model of an AIOL similar to that of FIG. 25A deformed;

FIG. 27 shows a model of the accommodation potential of the AIOL of FIG.24;

FIG. 28A shows a perspective sectional view of another AIOL, inaccordance with many embodiments;

FIG. 28B shows a model of the accommodation potential of the AIOL ofFIG. 28A;

FIG. 29 shows a perspective sectional view of yet another AIOL, inaccordance with many embodiments;

FIG. 30 shows the lenses associated with the AIOL of FIG. 29;

FIG. 31 shows a model of the accommodation potential of another AIOL, inaccordance with many embodiments;

FIG. 32 shows a model of the accommodation potential of yet anotherAIOL, in accordance with many embodiments;

FIG. 33 shows a schematic of the accommodation potential of an AIOL, inaccordance with many embodiments

FIG. 34A shows an AIOL in accordance with embodiments;

FIG. 34B shows internal pressure of the AIOL chamber as in FIG. 34B;

FIG. 35A shows an AIOL in accordance with embodiments;

FIG. 35B shows internal pressure of the AIOL chamber as in FIG. 35A;

FIG. 36 shows a method of manufacturing an AIOL, in accordance with manyembodiments;

FIG. 37 shows an optical structure deformed to provide optical power;

FIG. 38A shows an AIOL with an anterior-most portion of the AIOLanterior to the anterior most-portion of the haptic, in which thedeflectable member of the AIOL is configured to deflect in response totranslational and rotational movement of the haptic, in accordance withembodiments; and

FIG. 38B shows internal chamber pressure in response to loading of theAIOL as in FIG. 38A.

DETAILED DESCRIPTION

The AIOL as described herein can be used to provide improved vision, andcan be combined with one or more of many known surgical procedures andapparatus, such as cataract surgery and intra-ocular lens inserters. Theoptical structures of the AIOL are well suited for use with commerciallyavailable IOL power calculations based on biometry of the eye, and canbe used to provide improved vision. In many embodiments, a physician caninsert the AIOL as described herein in a manner similar to priornon-accommodating IOLs such that the AIOLs as described herein can bereadily used.

The structures of the AIOL as described herein can be combined in one ormore of many ways to provide an improved accommodating IOL. In manyembodiments, the AIOL comprises optical structures composed of a softmaterial, in which the optical structures are coupled to haptics, inorder to provide optical power with natural forces of the lens capsuleof the eye, as described herein, for example. In many embodiments, thedeflectable member comprises sufficient radial strength such that aradially inward force to an outer portion of the deflectable membercauses deflection of an inner portion of the deflectable member. Thedeflection may comprise a first order reversible buckling of thedeflectable member, for example. In many embodiments, the deflectablemember bends such that the inner portion comprises a convex curvaturealong the outer surface and the outer portion comprises an opposingconvex curvature along the outer surface. The convex inner portion maycomprise a disc shape and the outer concave portion may comprise anannular shape adjacent the disc shape. The arrangement of convex discshape and concave annular shape can provide two inflection points acrossthe diameter of the deflectable member, for example.

The radially extending deflectable member can be configured in one ormore of many ways to provide radial strength in order deflect to atleast the inner portion, for example with one or more of a modulus ofelasticity, a thickness, or a diameter.

The deflectable member can be coupled to the haptics in one or more ofmany ways so as to deflect when urged radially inward by the hapticsengaging the lens capsule. In many embodiments, the deflectable membercomprises sufficient radial strength to induce shape changes of at leastthe inner portion when the outer portion of the deflectable member isurged radially inward, or rotated, and combinations thereof. In manyembodiments, the deflectable member is coupled to the lens capsule suchthat rotation of the haptics relative to the stiff member induces aradially inward movement and rotational deflection of an outer portionof the deflectable member. Alternatively or in combination, the hapticscan be arranged to slide radially and in relation to the stiff member inorder to urge the deflectable member inward with radial force anddeflect the inner portion of the deflectable member with radial strengthof the outer portion. The deflectable member may comprise one or morestructures on the outer portion to encourage deflection, such as aconcave outer portion or thinner annular region to encourage concavedeflection of the outer portion and convex deflection of the innerportion, for example.

The present disclosure relates to devices, methods, and systemsassociated with an improved accommodating intraocular lens (AIOL). Someembodiments will comprise a central optical structure comprised of twodeformable lenses spaced apart along their optical axis, such as by alens support structure concentric with the optical axis of the lenses.The volume bounded by the lenses and optionally the lens supportstructure may be filled with an ionic solution, such as saline, or anon-ionic solutions such as dextrans or silicone oil. The opticalstructure in turn may be bounded by one or more haptic structures, thehaptic structures being either fluid-filled or of another embodiment,arranged in a plane normal to the optical axis of the lenses. The hapticstructures can be in fluid communication with the fluid bounded by theoptical structure. The transfer of fluid between the haptic structuresand the fluid-filled optical structure can change the accommodatingpower of the lenses by deforming one or both the lenses. Alternativelyor in combination, the haptic structures may directly exert mechanicalforces on the lenses of the fluid-filled optical structure to causedeformation and change accommodating power. The improved accommodatingintraocular lens system may additionally comprise any combination of thefeatures described herein.

The lenses and some of the support structures described herein willtypically be fabricated from a hydrophilic material that is opticallyclear when hydrated, swells on hydration by more than 10%, andaccommodates strain levels of greater than 100% when hydrated. Thematerial can be purchased as small disks and rods. For example, thehydrophilic material may comprise a copolymer of hydroxyethylmethacrylate (HEMA) and methyl methacrylate (MMA) such as CI18, CI21, orCI26 produced by Contamac Ltd. of the UK. These materials are alsodenoted as PMMA herein, and as used herein PMMA refers to a polymercomprising PMMA or a copolymer comprising PMMA, such as one or more ofPMMA polymer (hereinafter “poly(methyl methacrylate)”), or a copolymerof HEMA and PMMA such as p(HEMA-co-MMA), for example. As used hereinp(HEMA-co-MMA) refers to a copolymer of HEMA and PMMA and can also bereferred to as p(HEMA-MMA).

The copolymer may comprise one or more of a block copolymer (PPPP-HHHH),alternating copolymer (PHPHPHPH), statistical or random copolymer(PHPPHPHH), a star copolymer, a brush copolymer, or a graft copolymer,for example, where “P” identifies “MMA” and “H” identifies “HEMA”, forexample.

A used herein, a positive curvature of an outer surface encompasses aconvex curvature and a negative curvature of an outer surfaceencompasses a concave curvature.

As used herein, like reference numerals refer to like structures. Inmany embodiments as described herein, the reference numerals comprisethree or four digits in which the first one or two digits refer to thenumber of the drawing and the last two digits refer to like structuresamong figures having different numbers. For example, the referencenumerals 2503 and 3303 refer to similar deflectable members of FIGS. 25and 33, respectively. A person of ordinary skill in the art willrecognize that text describing a structure of one figure applies tosimilar structure of any other figure as provided herein.

In many embodiments, the deflectable member comprises an inner opticalportion and an outer extension portion, so as to concentrate and amplifyoptical power within the inner optical portion. The inner opticalportion can move away from the stiff member to comprise a convexlycurved outer surface providing an increased optical power. In addition,the outer portion may be deflected toward the stiff member so as tocomprise an opposite curvature and move toward the stiff member. Theoppositely curved outer portion can decrease the diameter of theoptically corrective portion in order to the concentrate optical powerchange within the inner portion. The optical power of the inner portionis related to the increased distance of the center of the inner portionfrom the stiff member, and the decreased distance from the outerextension portion to the stiff member. This combined effect of increasedinner separation distance and decreased outer separation distance has acombined effect on increase optical power. Also, as the optical power ofthe lens can decrease approximately as the square of the diameter of thelens, the decreased diameter of the inner portion provided with theoppositely curved outer portion can further increase the optical powerof the lens.

In some embodiments, the intraocular lens/lens system and/or othercomponents defining the lens chamber or fluid optical element are filledwith a water-based clear fluid with a refractive index higher thanwater, in order to increase the optical power of the system. The highrefractive index of the lens chamber liquid may be caused by thepresence of solutes. Such solutes often comprise large moleculesincapable of crossing the chamber defining components. Examples of suchlarge molecules include dextrans, with exemplary molecular weights of<40 kD, <701 kD, <500 kD, and <1000 kD. Further examples of such solutesinclude sugar molecules. The solutes and water may compose a dilutedsolution having an osmolality. Such osmolality may cause the movement ofwater into or out of the chamber to achieve an osmotic equilibriumvolume. Such volume can be adequate to produce the appropriate opticalpower in the system to the desired power for the patient.

Each of the accommodating IOLs as described herein comprises an anteriorside and a posterior side. A nodal point of the lens is preferablylocated along an optical axis of the lens at a midpoint located alongthe optical axis approximately equidistant from the anterior andposterior surfaces of the optical structure of the lens. In manyembodiments, the nodal point of the lens is located away from a planeextending between the peripheral haptic lever structures so as to definean anterior posterior orientation of the lens. The anterior to posteriororientation of the lens can be reversed by a person of ordinary skill inthe art based on the teachings disclosed herein.

The soft material of the optical structures of the AIOL can be shaped inone or more of many ways, and may comprise machined components, ormolded components, and combinations thereof, for example.

An improved accommodating intraocular lens can have a reduced deliverycross section. The reduced delivery cross section can be facilitated byan optical structure capable of translating from a deliveryconfiguration to an operational configuration. The optical structure mayhave a small dimension along the optical axis in the deliveryconfiguration and larger dimension along the optical axis in operationalconfiguration. Also, a lens support structure can be configured tomaintain the distance between the periphery of the two lenses in theoperational configuration and to allow fluid to pass between the hapticstructures and the fluid volume bounded by the optical structure ineither configuration.

The delivery cross section may be attained by folding or rolling theAIOL around a delivery axis normal to the optical axis. The deliverycross section may be measured as the largest dimension in the deliveryconfiguration measured in a plane normal to the delivery axis. Deliverycross sections attainable for the AIOLs disclosed herein may be lessthan 4.5 mm, and preferably less than 2.5 mm. In alternate embodiments,the delivery cross section can be attained by forcing the AIOL through atube or delivery aperture. Such a tube may be conical in cross sectionsuch that the AIOL may be compressed as it progresses down the tube. Thedistal end may be sized to interface with an incision in the eye.Delivery may be facilitated by syringes or plungers.

The intraocular lens system may be comprised of at least two hydrophilicPMMA lenses where PMMA denotes a compound comprising one or more ofpolymethyl methacrylate (PMMA), polyhydroxyethyl methacrylate (PHEMA),hydroxyethyl methacrylate (HEMA), or methyl methacrylate (MMA), forexample. The lens system may include other elements comprised of any orany combination of the following materials: NiTi, polyurethane,hydrophilic PMMA, photo activated polymers, precursors to PMMA, ethyleneglycol dimethylacrylate (EGDMA), silicones, silicone copolymers, amongothers.

One or more of the substantially planar member or the plano convexmember may comprise a polymeric material. The polymeric material maycomprise a material, available, for example, from Contamac Ltd. of theUK or Vista Optics Ltd. of the UK. For example, the PMMA copolymer maybe selected from the list comprising a Definitive 50 material, aDefinitive 65 material, a Definitive 74 material, a Filcon V3 material,a Filcon V4 material, a Filcon V5 material, an Optimum Classic material,an Optimum Comfort material, an Optimum Extra material, an Optimum Extra16 material, an Optimum Extra 18.25 mm material, an Optimum Extra 19 mmmaterial, an Optimum Extra 21 mm material, an Optimum Extreme material,an F2 material, an F2 Low material, an F2 Mid material, an F2 Highmaterial, a Focon III 2 material, a Focon III 3 material, a Focon III 4material, a Hybrid FS material, a Contaflex GM Advance material, aContaflex GM Advance 49% material, a Contaflex GM Advance 58% material,a Filcon I 2 material, a Filcon II 2 material, a Contaflex GM3 49%material, a Contaflex GM3 58% material, a Contaflex material, aContaflex 58% material, a Contaflex 67% material, a Contaflex 75%material, a Polymacon 38% material, a Hefilcon 45% material, aMethafilcon 55% material, a Filcon I1 material, a Filcon IV 2 material,an HI56 material, a PMMA material, a CI26 material, a CI26Y material, aCI18 material, and other variants available from Contamac Ltd. of the UKand a Vistaflex GL 59 material, a HEMA/GMA material, an Advantage+49material, an Advantage+59 material, a Filcon I 1 material, a Filcon 12material, a VSO nVP material, a nVP/MMA material, a VSO 60 material, aVSO 68 material, a VSO 75 material, a Filcon II 1 material, a Filcon II2 material, a VSO pHEMA material, a pHEMA material, a HEMA material, aVSO 38 material, a VSO 42 material, a VSO 50 material, a Vistaflex 67Clear UV material, a polysiloxy-acrylate material, an AddVALUE SiliconeAcrylate material, an AddVALUE 18 material, an AddVALUE 35 material, apoly-fluoro-silicon-acrylate material, an AddVALUE Fluor SiliconeAcrylate material, an AddVALUE 25 material, an AddVALUE 50 material, anAddVALUE 75 material, an AddVALUE 100 material, a Scleral Rigid GasPermeable material, a hydrophobic intraocular lens material, a VOPhobicClear Tg 16 material, a VOPhobic Yellow Tg 16 material, a hydrophilicintraocular lens material, a HEMA-MMA copolymer material, an IOSoftmaterial, an IOSoft clear material, an IOSoft yellow material, a PMMAmaterial, a Vistacryl CQ UV material, a Vistacryl XL blue material, aVistacryl CQ material, and other variants available from Vista OpticsLtd. of the UK. Often, the polymeric material may be one or more ofwater permeable and hydrophilic. Water present in the lens capsule ofthe patient's eye may transfer into or out of the fluid optical elementthrough the polymeric material to achieve an osmotic equilibrium withfluid present in the lens capsule when the intraocular lens is placedtherein. The polymeric material may be non-permeable to silicone oil.The polymeric material may be non-permeable to compounds havingmolecular weights of greater than 40 kDa.

In some embodiments, an AIOL is inserted into and interfaced to thenatural capsule such that the interface zones create a seal which formsa semi toroidal region of capsule, where fluid transfer between the semitoroidal region and the interior of the AIOL causes an accommodationchange in the AIOL. In such embodiments, fluid such as saline may beinjected into the semi toroidal region.

In some embodiments, the optical structure is comprised of a materialwhich is changed from a delivery configuration to an operationconfiguration after introduction into the capsule of the eye. One suchmaterial may comprise a photoactive polymer which in the deliveryconfiguration is a liquid which is hardened by photo activation afterintroduction. Another such material may comprise a memory metal such asan NiTi alloy which in the delivery configuration has a thin dimensionin a plane normal to the optical axis and after introduction isinitiated to change to an operational configuration by heating viainductive coupling. In other embodiments, the NiTi may rely on its superelastic characteristics to shift from a delivery to an operationalconfiguration.

The optical structure in some embodiments is mechanically more stable inthe operational configuration than in the delivery configuration, andspontaneously changes from a delivery configuration to an operationalconfiguration after introduction into the capsule of the eye. In such aconfiguration, the optical structure may be coaxed into a deliveryconfiguration just prior to delivery or at manufacture. One such systemmay comprise a super elastic metal element which springs from thedelivery configuration upon introduction of the device into the capsule.

In some embodiments, the lens support structure and one lens aremachined or molded as a single structure and the second lens is affixedto the support structure by a bonding means. In many other embodiments,the AIOL is comprised of two halves, each incorporating a lens, whichare bonded together to form the optical structure. Such embodiments mayincorporate the haptic structures. In yet other embodiments, a secondmachining operation can be performed on the bonded structure. Alternatebonding means may include mechanical interfaces such as threading wherethe outer periphery of the lens is threaded and the inner surface of thesupport structure is threaded. In alternate embodiments, the interfacecan be a simple interference fit. In some embodiments, affixingcomprises bonding the materials by treating the one or both of theseparate bonding surfaces with a precursor monomer, then assembling thestructure, applying a load across the bonding surfaces, and heating theassembly for a period of time. Such a process may facilitate crosslinking between the material comprising both parts. In some instances,the precursor monomer may be mixed with small particles of the polymer.Bonding agents may additionally include urethanes, silicones, epoxies,acrylics, amongst others.

In the devices of the present disclosure, the lenses may be compromisedof a water and ion permeable material. In some embodiments, the AIOL canbe allowed to self-fill after implantation, thereby minimizing thedelivery cross section.

In alternate embodiments, the AIOL is filled after implantation.

FIG. 1 illustrates an accommodating intraocular lens (AIOL) system orintraocular lens 10 comprised of a central lens support structure 11,two haptics structures 12, two deflectable lenses 13 of which only oneis visible in FIG. 1, and two compression bands 14. The hapticsstructures 12 may comprise thin walled structures configured to deformunder minimal loads and comprised of an elastomeric material. Theinternal volume of the AIOL 10 can be filled with a clear fluid such assaline of comparable osmolality to that of the fluids in the eye aroundthe lens capsule. Alternatively, the AIOL 10 can be filled with fluidsof high refractive index as described elsewhere herein. The lenses 13are interfaced to the support structure 11 such that as fluid transfersfrom the haptics into the internal volume of the support structure thelenses are caused to deflect thereby changing their accommodative power.

A side view of the lens support structure 11 of FIG. 1 along with twolenses 13 is illustrated in FIG. 2. The lenses 13 may be of the sameshape or may have differing shapes. Also visible in FIG. 2 are thehaptic structure interface features 15 comprised in the lens supportstructure 11. The open end of the haptics structures 12 are fit over thehaptic structure interface features 15 and are further affixed to thelens support structure interface feature 15 using compression bands 14.Additionally, in some embodiments, an adhesive or sealant such assilicone may be used. In alternate embodiments, a press fit may be used.In yet other embodiments, the haptics 12 may be molded onto a hapticinterface. In one embodiment, the haptic 12 is molded onto a PMMA barbwhich is then bonded to the support structure 11. Said bonding may be byadhesive or facilitating cross linking between the barb and the supportstructure as described below herein. Materials for the haptic structures12 and haptic structure interfacing may include any or any combinationof silicone, PEBAX, urethane, copolymers of PMMA and silicone, or otherelastomeric material. The distance between the periphery of the lenses13 may be maintained by the support structure 11 while the center of thelenses are allowed to deflect as the fluid volume within the supportstructure 11 increases, thereby changing the accommodative power of thestructure. In some embodiments, the haptic structures 12 may befabricated from an extrusion.

FIG. 3 illustrates a lens support structure 31 in which one of the twolenses, first lens 36, is comprised in or integral with the supportstructure 31. The second lens, lens 33, in the embodiment of FIG. 3 isconfigured to interface to the support structure 31 via threads 37. Astructure 35 extends outward to couple the lens body to haptics.

Another embodiment for a central support structure similar to that shownin FIG. 3 is illustrated in FIG. 4. In this embodiment, the second lens43 is interfaced via an interference fit. In some embodiments, theinterference fit may be further sealed through the use of a sealant oradhesive. The interference fit is further facilitated by the procedureused to assemble and rehydrate the components. One such procedure asimplemented on the support structure 41 shown in FIG. 4 is as follows:the bottom of the support structure 41 comprising lens 46 is hydrated,lens 43 in the unhydrated condition is then fitted into the groovecomprised in the support structure 41, the support structure 41 andlenses 43 and 46 are allowed to completely hydrate, and, if required, asealant or adhesive is then applied. The use of interference fits canminimize the requirement and or amount of bonding agent.

FIG. 5 illustrates another embodiment of an AIOL 50 in which half of thesupport structure 51 and haptic structures 52 are comprised in an upperand lower half of the AIOL 50 and thereby all fabricated from the samematerial. The two halves are bonded together at seam 59 to form thecomplete haptic and support structure 51. Lens 53 may either be integralto the half structures or bonded to the support structure 51. In themanufacturing environment, allowing one lens to be aligned and bondedafter the fabrication of the rest of the structure can provide anadvantage in assuring the optical axis of the two lenses are preciselyaligned.

In the embodiments shown in FIGS. 1 and 2, the haptic structures 12 areconfigured in such a fashion that they may be folded out and away fromthe support structure 11 in a plane normal to the optical axis of thelenses. Such a configuration can facilitate a reduction in deliverycross section for a fluid-filled device. In the embodiments shown inFIGS. 6 and 7, the haptic structures are both integral to the lenssupport structure and attached continuously around the perimeter of thelens support structure.

FIG. 6 illustrates an embodiment of an AIOL 60 wherein the hapticstructure 62 and support structure 61 are integral and are configured asa toroid-like structure. The inner radius of the toroid-like structurecomprising the support structure 61. Fluid may be allowed to flowbetween the haptic structure 62 and the inner volume of the supportstructure 61 through openings 67. The AIOL 60 can be fabricated bybonding the two halves at seam 59. Lens 63 may be integral with thehalves are bonded separately to the halves.

A variation on the embodiment of FIG. 6 is illustrated in FIG. 7. Theembodiment of the AIOL 70 incorporates features which help to reduce thedelivery cross section. Half of the support structure may be comprisedon each the upper and lower halves on the AIOL 70 and may be comprisedof a series of structures 71 each separated by a space forming acastellated ring. Castellated structures can be meshed at assembly priorto bonding at seam 79. Spring ring 79 can fit in a grove and can lockthe upper and lower halves of the structure relative to displacementsalong the optical axis. As shown in FIG. 7, lenses 73 can be integral tothe half structures comprising the AIOL 70. In other embodiments, thelenses 73 may be separate and bonded at another time. In suchembodiments, the support structure can be capable of greater deformationduring delivery as the castellated elements can fold over a greaterradius of curvature. AIOL 70 may also comprise feature 78, which canallow for a means of applying pressure directly across seam 79 duringthe bonding process. The surfaces which comprise the seam mayadditionally incorporate chamfers or fillets to direct the flow ofbonding agents and minimize the likelihood of creating voids.

FIG. 8 represents an embodiment of an AIOL 80 which comprises anelastomeric support structure 81 filled with a fluid capable of beinghardened after delivery of the AIOL. Such fluids may be optically curedand may comprise, for example, a UV curing silicone or epoxy, a pH curedfluid such as a collagen solution, or a heat cured fluid where thematerial comprises a suspension of particle capable of being inductivelyheated such as magnetite particles. Channels 87 can allow fluid to passbetween the haptic and the central volume of the support structure.

In alternate embodiments, the support structure 81 of AIOL 80 may bereplaced with a support structure 91 as indicated in the expandedconfiguration of AIOL 80 shown in FIG. 9A, or by support structure 98comprising channel structures 87 as indicated in FIGS. 9B and 9C, whichmay be comprised of a memory metal which can be flattened to comprise aflattened configuration 99 as indicated in FIG. 9B prior to assemblythen heated by inductive coupling allowing it to take an operationalconfiguration after delivery as indicated in FIG. 9C. Such aconfiguration may provide for a reduced cross section.

Embodiments described herein also allow for sequencing the assembly andthe use of long setting, heat, pressure, and/or optical initiatedbonding materials to insure proper optical alignment of the lenses.

Bonding of a copolymer of HEMA and MMA may be facilitated by treatingthe bond surfaces with EGDMA or triethylene glycol dimethylacrylate(TEGDMA) and then subjecting the bonded surfaces to pressure andtemperature. Treatments may include but is not limited to vaportreatment, wetting, wetting and allowing for evaporation, applying amixture of EGDMA or TEGDMA and particles of a copolymer of hydroxyethylmethacrylate and methyl methacrylate. In one such procedure, 40 micronbeads of a copolymer of HEMA and MMA can be mixed with EGDMA and used asa bonding agent. Such a bonding scheme can provide advantage in thatthere can be no or minimal seam and the mechanical properties of thebonded inter face have the same mechanical properties as the structure.

Delivery procedures may vary and will depend on the embodiment of thedevice. In one delivery procedure for an AIOL, which is typicallypre-filled with an operating fluid at manufacturing and ready for use, adevice can be selected for size and base accommodating power to matchthe patient's requirements. The eye can be prepared according tostandard procedures typical for the instillation of non-accommodatinglenses, with the possible exception that the incision may be larger insome embodiments. The AIOL may be loaded into an injector and theninjected into the prepared eye capsule. The AIOL can then be adjustedfor position. In an alternate delivery procedure, the lens may be filledat the time of surgery. In such a procedure filling can comprise sizingthe AIOL and or setting the base power of the AIOL. To accommodate sucha procedure the device may incorporate a filling port which can besealable by bonding prior to implantation or a port comprising a selfsealing material such as an elastomeric material.

In yet a further alternative, the AIOL may be filled after implant,thereby minimizing the delivery cross section. In such embodiments,after implant, the device may be filled via a filling port as previouslydescribed. In alternate embodiments, the device may be initially be in aless than fully hydrated state and allowed to become fully hydratedafter implantation, such as by self filling with fluids naturallyavailable in the eye. For example, the AIOL may comprise a material in aless than fully hydrated state, such as a fluid element within the AIOL,which can be fully hydrated by fluid from the eye and is inhibited fromleaking from the AIOL during the hydration process. Such embodiments mayrely on the permeability to water and small molecules of materialscomprised in the AIOL. In such procedures, a device properly sized andfilled with an appropriate operating fluid, typically a saline solutionswith an osmolality and ionic balance comparable to the fluids naturallyoccurring in the eye, can be prepared for implant by subjecting it to ahypertonic solution of large molecules such as a solution of super highmolecular weight dextran. This pretreatment can draw fluid out of theAIOL prior to implant, thereby decreasing its delivery cross section.The AIOL can then be implanted through an incision of the eye. Afterimplant, the AIOL may scavenge fluid from the eye renewing its fluid andoptic equilibrium. In some embodiments, the osmolality of the AIOL mayfurther be adjusted by the incorporation of a molecule too large todiffuse through materials comprising the AIOL at the time ofmanufacture. In such systems, the equilibrium fill pressure for the AIOLmay be adjusted or set on filling.

FIG. 10 depicts an AIOL with alternate haptic structures where a fluidchamber is formed by sealing the equatorial region of the capsule 1002at the locations 1004 and 1005. Equatorial chamber 1002 can communicatewith posterior chamber 1006 by holes 1007 in the structure of the AIOL.Movement of the ciliary body can cause the fluid of chamber 1002 to goin and out of chamber 1006, deflecting the single optical element 1003and providing accommodation.

Chambers 1002 and 1006 can be filled either naturally, as with aqueous,or with other fluids such as saline; viscous cohesive fluids may be usedto prevent leakage at contact locations 1004 and 1005.

Various methods to improve sealing may be employed at locations 1004 and1005. Glue may be applied as a bond to the capsule; fibrogenicmechanisms may be induced; sharp protrusions may be provided at contactpoints to increase sealing against the capsule by indenting it; anteriorcontact location 1005 can be provided with means to capture the edge ofthe capsulorhexis 1001.

Optical element 1003 can be provided with means of hinging along theedges of the optical area to increase deflection and displacement, andtherefore optical power.

The assembly could have external envelope with dimensions close to thecrystalline, and therefore minimize the chance of capsular contraction.

There could be less sizing issues due the absence of conventionalhaptics, the only relevant capsular dimension may be its height.

The system may be indifferent to osmotic variations in the aqueoushumor.

To reduce chance of leakage, the as cut dimensions could be in theaccommodated geometry.

FIG. 11 shows an alternative AIOL, in accordance with many embodiments,which incorporates two optical element lens system with hapticstructures configured to form a fluid chamber by sealing the equatorialand posterior regions of the lens capsule. Additional posterior opticalelement 1101 defines the fluid optical element or fluid chamber 1102 andmay be provided for optical reasons (e.g., establishing fluid chamber1102 and providing improved optical accommodation.)

FIG. 12 shows an alternative AIOL, in accordance with many embodiments,which incorporates two optical elements with haptic structuresconfigured to form a fluid chamber by sealing the equatorial andposterior regions of the lens capsule and where a thin membrane 1201 canbe attached to the structure to contain the fluid.

FIG. 13 shows an alternative AIOL, in accordance with many embodiments,which has haptic structures configured to form a fluid chamber bysealing the equatorial and posterior regions of the lens capsuleincorporating one optical element and where a thin membrane 1301 can beattached to the structure to contain the fluid on a single opticalelement implementation.

FIGS. 14A and 14B illustrate an alternate AIOL, in accordance with manyembodiments, where a single optical element lens support structure 1401is uniformly open circumferentially along the perimeter of the deviceand where said lens support structure is not connected to fluid-filledor other conventional haptics. The AIOL device is shown in FIGS. 14A and14B as resting in lens capsule receiving structure 1405, and lenssupport structure 1401 is in contact with the posterior lens capsule at1402 and is also in contact with the anterior lens capsule at 1403. Thedevice can be positioned such that the anterior capsule opening 1404 andlens support structure 1401 may be aligned with the capsulorhexis 1408in some fashion as to affect a working mechanical seal, described below.FIG. 14B illustrates the installed AIOL, post surgery, where the lenscapsule has conformed to the installed device and provides the sealrequired to create chambers 1405 and 1406 for the activation and reliefof accommodation in the lens. The AIOL can be inserted into andinterfaced to the natural capsule such that the attachment zones seal asemi toroidal region of capsule. Fluid transfer between thesemi-toroidal region and the interior of the AIOL can causes anaccommodation change in the AIOL.

FIGS. 15 through 23B illustrate alternate AIOL embodiment with anemphasis on their manufacture. FIG. 15 is an optical sub-assemblycomprised of anterior lens element 1501 and posterior lens element 1502.Optical fluid channels 1503 allow fluid to enter fluid optical elementor optical chamber 1504 and the sub-assembly is bonded to lens supportstructure 1601 at mounting hole 1505.

FIGS. 16A and 16B depict the optical sub-assembly of FIG. 15 insertmolded into lens support structure 1601 and with contact points 1602 and1603 bonded together at 1604 to complete the AIOL assembly.

FIG. 17 shows a modified embodiment of the aforementioned in FIG. 16incorporating posterior opacification cell dam 1701 and capsulorhexissupport flange 1702.

FIG. 18 illustrates an AIOL final assembly where optical sub-assembly1806 is insert molded into lens support structure 1805 with hapticstructure 1801 bonded to 1805 at points 1802 and 1803, creating hapticfluid chamber 1804. This configuration may alternately incorporate alens such as that illustrated in FIG. 19 where optical assembly 1901 isbonded, using either solvent or heat, to support structure 1903 atinsert posts 1902. The lens system of FIG. 19 seals after assembly byhydrating the lens system until it swells approximately 10% therebyresulting in a fluid-tight force-fit.

FIG. 20 is a top view of an AIOL incorporating an optical assembly suchas that depicted in FIG. 19. Insertion and bonding points 2001 areshown. Accommodation can occur when fluid channels 2002 allow transferof fluid into fluid optical element or lens chamber 2005 as hapticstructures 2003 are compressed by the equatorial perimeter of the lenscapsule (not shown). Haptic relief 2004 can provide for minimalcircumferential stress during compression and quick recovery to thenon-accommodating position when compression is relaxed.

FIG. 21A is a lateral sectional view of the AIOL in FIG. 20 indicatingpoints 2101 of minimal deformation in the haptic structure, and FIG. 21Bdepicts the deformations of the haptic structure given physiologicallyrelevant loadings on the haptic structure. FIG. 22 is an isometric viewof the AIOL assembly of FIGS. 20, 21A, and 21B.

FIG. 23A is an alternate embodiment and assembly method wherein lenssystem 2302 is insert molded into haptic structure enclosure 2303. FIG.23B shows the completed AIOL assembly with sealed haptic seam 2307,creating haptic chamber 2308.

FIG. 24 depicts an alternate low-profile AIOL with alternate hapticstructures and support structure comprised of the optical structure asdescribed herein, posterior haptic structure 2406, and anterior hapticstructure 2407. The optical structure can be aligned and secured viamounting to post 2402 and post 2402 can be bonded at point 2401. Ahaptic seam 2442 can be bonded to form a seal and create a haptic fluidreservoir 2404. In such embodiments, the bonding at point 2401 and thehaptic seam 2442 can form a fluid-tight seal to prevent fluid fromleaking into and/or out of the haptic fluid reservoir 2404. The opticalstructure 2405 may comprise an anterior planar member that may bedeflectable and a posterior plano convex member that may be resistant todeflection.

The embodiments described herein can be combined in one or more of manyways. For example, the embodiments of FIGS. 25A to 28B and 31 to 35B canbe combined so as to include similar or alternative structures asdescribed herein, and combinations thereof, in which the last two digitsof the identifying numbers of the figures identify like structures.

FIG. 25A shows a model of the accommodation potential of the AIOLsimilar to that of FIG. 24. The AIOL comprises an undeflectedconfiguration 2521 for far vision and a deflected configuration 2522 fornear vision. The AIOL is shown in a non-accommodating configuration witha planar configuration of anterior planar deflectable member 2503coupled to lever haptic structure 2502. An outer structure of haptic2502 is configured to engage the lens capsule, and may comprisestructures to reduce pressure on the capsule as described herein. Astiff member 2510 may comprise a lens to provide optical power for farvision. The deflectable member 2503 may comprise a substantially planarmember having a substantially constant thickness, for example. Thedeflectable member 2503 comprises an inner optical portion 2525 and anextension 2511. Extension 2511 extends between the inner optical portion2525 and the rotating haptic structure 2502. When the inner opticalportion 2525 comprises the convex deflection 2524, the fluid of thechamber beneath the inner optical portion is shaped to provide anoptical correction.

The deflectable member 2503 and stiff member 2510 define at least aportion of an inner chamber 2512. The inner chamber 2512 comprises afluid having an index of refraction greater than an index of refractionof an aqueous humor of the eye. When the deflectable member 2503comprises an increased curvature, the internal fluid comprises a convexlens shape and provides additional optical power.

The AIOL comprises a central thickness extending from an outer surfaceof the stiff member 2510 to an outer surface of the deflectable member2503. The central thickness may comprise a first central thickness 2530of the AIOL lens in a far vision configuration, and a second centralthickness 2531 of the AIOL lens in a near vision configuration. Theincrease in thickness of the lens centrally is related to the increasedoptical power of the lens. The increased optical power of the lens isalso approximately inversely related to a square of the diameter of thecentral optical portion. The extension portion can decrease the diameterof the optical portion and provide increased optical power for an amountof change between first distance 2530 and second distance 2531.

The stiff member 2510 is connected to haptic structure 2502, such thatthe haptic structure 2502 rotates when the lens accommodates for nearvision. The haptic structure 2502 extends to a first anchor region suchas an anchor point 2540 about which the haptic rotates relative to thestiff member 2510. The haptic structure extends a distance from thefirst anchor region to the wall of the lens capsule. The hapticstructure 2502 extends to a second anchor region such as second anchorpoint 2541. The second anchor region 2541 couples to the deflectablemember 2503 in order to induce inward force on the deflectable member.The distance from the first region to the outer structure of the hapticengaging the lens capsule is greater than the distance from the firstregion to the second region. This difference in distance providesmechanical leverage of the lens capsule forces on the deflectable member2503. The force of the lens capsule on the deflectable member 2502induces a convex deflection 2524 of the deflectable membrane. Theextension 2511 comprises an opposite concave curvature.

Although the extension portion may comprise an opposite concavecurvature, this curvature can be provided in one or more of many ways todecrease visual artifacts. The amount of accommodative opticalcorrection can be approximately 2 to 10 Diopters, such that the oppositecurvature of the extension portion may comprise no patient perceptibleoptical affect. Also, the eye naturally comprises spherical aberration,and small amounts of aberration may not be perceptible. Further, thelens can be sized such that the pupil covers at least a portion of theoppositely curved concave portion. In at least some embodiments, thethickness profile of the extension portion of the deflectable componentcan be thinner to localize the opposing curvature to the thinner outerportion of the deflectable member. Work in relation to embodimentssuggests that the substantially planar deflectable member decreasesvisual artifacts that may occur with internal reflections, for example,although a curved deflectable member can be provided and configured toinhibit visual artifacts related to internal reflections.

In many embodiments, the haptic 2502 comprises an outer reservoircoupled to chamber 2512, and forces of the haptic to the outer reservoircan urge fluid toward the chamber 2512 when the eye accommodates, inaddition to inward forces of the haptic 2502 at anchor point 2541, forexample.

The AIOLs as described herein can be studied with finite elementmodeling. While the finite element modeling can be performed in one ormore of many ways, in many embodiments, the finite element modeling isperformed with known commercially available software such as Abaqus,known to a person of ordinary skill in the art. The lenses as describedherein can be modeled with a finite element mesh and known materialproperties of one or more materials as described herein, and theresponse of the AIOL to lens capsule forces determined.

A person of ordinary skill in the art can take the finite elementmodeling output of the lenses as described herein and determine theoptical power of the AIOL in response to lens capsule force, forexample, in order to determine appropriate AIOL parameters to provideaccommodation to the eye. At least FIGS. 25A to 28B and 31 to 35B showresponses of an AIOL to forces of the capsular bag in accordance withembodiments.

FIG. 25B shows a sectional view of the model from which FIG. 25A wasdeveloped. Note that the lens or optical structure comprises additionalspace between the individual lenses and that the posterior and anteriorhaptic structures 2506 and 2507 incorporate an additional mating surface2508. In such embodiments, the haptic structures 2506, 2507 may be overmolded onto the lens or optical structure(s) 2503. The haptic structures2506, 2507 may be comprised of a thermoplastic or solvent weldablematerial thereby facilitating the joining of the two halves. Thefeatures comprising mating surface 2508 may also include fluid paths2509 or locating and alignment features not shown.

In embodiments according to the AIOL of FIG. 25A-25C, the deflection ofthe deflectable structure or lens 2503 may be primarily driven bymechanical forces applied to the peripheral edge of haptic structure2502 transmitted to the deflectable structure or lens 2503 by theintermediary portion of the haptic structure 2502. Since the deflectablestructure or lens 2503 does not sit directly on the non-deflecting lens2510, the deflectable structure or lens 2503 may be allowed to buckle asshown. In such embodiments, the deflection experienced by thedeflectable lens or structure 2503 will increase the accommodating powerof fluid optical element or lens created between the deflectablestructure or lens 2503 and non-deflecting structure or lens 2510 and thevolume of the fluid optical element will increase as accommodating powerincreases. Additional optical fluid may therefore be required andprovided from the reservoir comprised in the haptic structure 2502 viachannels 2509.

FIG. 26 represents a variation on the AIOL of FIGS. 25A-25C, wherein theanterior haptic structure 2602 has been stiffened at haptic structurewall 2606 to better couple forces into the deflectable structure 2603.Forces provided from the equatorial region of the capsular structure ofthe eye are coupled via the periphery of the haptic structure 2602creating a moment around flexural point 2611. The moment produces anoutward deflection of deflectable structure 2603.

FIG. 27 is a representation of the accommodating potential of the AIOLsimilar to that of FIG. 24. The AIOL includes a deflectable structure oranterior lens 2703, a stiff or non-deflectable member 2710, and a hapticstructure 2702 supporting the deflectable structure 2703 and stiffmember 2710. The deflectable member 2703 can be located on the anteriorportion of the AIOL and the stiff member 2710 can be located on theposterior portion of the AIOL when placed in the eye. In thisembodiment, the haptic wall 2706 of haptic structure 2702 is coupled toa haptic reservoir 2707 in fluid communication (e.g., through fluidchannels) with a fluid lens structure of inner chamber 2712 of the AIOL.Deflections of deflectable member 2703 of the optical structure can beprovided at least in part by fluid pressure created by the deflection ofthe haptic structure 2702 and haptic wall 2706. For example, theperiphery of the haptic structure 2702 can be rotated by forces appliedto the periphery of the haptic structure 2702 (e.g., inward forces ofthe capsular structures), causing in turn an inward collapse in thehaptic reservoir 2707 thereby increasing the pressure within andtransferring fluid from the haptic reservoir 2707 into the fluid lensstructure 2712. The increase in volume of fluid lens structure 2712 cancause the deflectable member 2703 to move anteriorly relative to thestiff member 2710, thereby increasing in curvature and increasing theoptical power of the eye. In some embodiments, the rotation of thehaptic structure 2702 can further cause the deflectable structure 2703and the stiff member 2710 to move together relative to the hapticstructure 2702 in a direction opposite of the direction of rotation toincrease the optical power of the eye.

FIGS. 28A and 28B illustrate a variation on the AIOL of FIGS. 25 and 26.FIG. 28A shows a half section of the AIOL. The AIOL is comprised of anoptical or lens structure 2805, in turn comprised of a deflectablestructure or member 2803, a stiff or non-deflectable lens or member2810, and a fluid-filled lens chamber or fluid optical element 2812. Theoptical or lens structure 2805 can be held together by a hapticstructure 2802. The haptic structure 2802 may comprises an alignmentstructure 2816 upon which the elements of the AIOL can be stacked duringassembly. The alignment structure 2816 may also comprise alignment posts2822 and a diaphragm element 2826. The other elements include a spacer2814 and a cover seal 2815. The materials from which the hapticstructure 2802 is comprised are typically solvent and or heat weldable.The spacer element 2814 comprises channeling which facilitates fluidcommunication between the fluid-filled lens chamber 2812 and the hapticreservoir 2813 comprising diaphragm 2826. The fluid-filled lens chamber2812 and the haptic reservoir 2813 may form a closed system such as asealed reservoir. In this embodiment, the haptic reservoir 2813 is notdeformed as by the activation forces applied to the periphery of thehaptic structure 2802. Instead, the diaphragm element 2826, which may beisolated from experiencing direct forces delivered from the capsularstructure of the eye, deflects in accommodation of the pressure changeswithin the fluid-filled lens chamber or fluid optical element 2812.Diaphragm element 2826 may be fluidly coupled to the fluid-filled lenschamber 2812 such that an anterior deflection of diaphragm element 2826,as shown in FIG. 28B, corresponds to an increase in the volume offluid-filled lens chamber 2812 and a posterior deflection of deflectablestructure 2803. Such embodiments may have advantage when it is desiredto use only the forces generated at the equatorial region of the capsuleto mediate accommodation. In such embodiments, pressure in internal lenschamber can be negative.

In many of the embodiments described above, such as those of FIGS. 24through 28B, the AIOL will be assembled when all of its components arein a dry state. Where the optical or lens structures are comprised ofhydrophilic PMMA copolymers, the system will be hydrated at thecompletion of assembly. When hydrated, the hydrophilic lens componentswill swell thereby enhancing the sealing of the chambers within thestructure.

FIG. 29 shows an embodiment of an AIOL wherein the lens or opticalstructure is created by over molding a lens 2910 into each of two halvesof the AIOL 2906 and 2907. As shown, the lenses are the same. In someembodiments, however, it may be desirable that they are different suchas when one lens is deflectable and the other not. The haptic structure2902 comprising the haptic fluid chamber 2913 can be created on assemblyby folding the peripheral element of the structure 2906 and bonding itto a bond surface 2903. In this embodiment, the seam 2908 may be leftun-bonded. In such embodiments, as pressure is applied to the outersurface of the haptic structures 2902, lenses 2910 will be displaced anddeflected. Such structures may also provide advantage by minimizing thedelivery cross section, as the upper and lower halves can telescope oneach other when the structure is compressed.

FIG. 30 illustrates a lens structure from the AIOL of FIG. 29incorporating a hole feature 2920 which facilitates fixation of thecomponents of the haptic structure 2902 when the lens is over-moldedinto a either half of the AIOL structure.

FIG. 31 shows an embodiment of an AIOL 3100 comprising a deflectablemember 3103 comprising a concave region 3111, a stiff or non-deflectablemember 3110, and a fluid-filled chamber 3112. In this embodiment, theconcave surface of concave member 3111 causes an inward deflection ofthe central portion of the concave region 3111 relative to the stiff ornon-deflectable member to produce an outward deflection of deflectablemember 3103 relative to the stiff or non-deflectable member into aconvex configuration. In many embodiments, the inward deflection of theconcave region 3111 is in the anterior direction and the outwarddeflection of the central portion of the concave member 3111 is in theposterior direction when the AIOL 3100 is placed in the lens capsule, orvice versa in alternative embodiments. In many embodiments, the concaveregion 3111 has a uniform thickness.

FIG. 32 shows an embodiment of an AIOL 3200 comprising a deflectablemember 3203 comprising a concave region 3211, a stiff or non-deflectablemember 3210, a fluid-filled lens chamber 3212, and a haptic structurecomprising a wall 3221. In this embodiment, the concave surface ofconcave member 3211 converts a rotation of the haptic and hapticstructure wall 3221 relative to stiff member 3210 into an outwarddeflection of deflectable member 3203 relative to stiff member 3210,such that a center of the deflectable member 3203 separates from stiffmember 3210 as the outer portion of the deflectable member moves towardthe stiff member. In many embodiments, the inward deflection of theconcave region 3211 is in the anterior direction and the outwarddeflection of the central portion of the concave member 3211 is in theposterior direction when the AIOL 3200 is placed in the lens capsule, orvice versa in alternative embodiments. In many embodiments, the concaveregion 3211 thins the remainder of the deflectable member 3203 so as toact as a hinge. For example, the concave region 3211 may comprise aconcave cut-out of an external surface region of the deflectable member3203.

FIG. 33 shows a schematic of an AIOL in an undeflected configuration3321 and a deflected configuration 3322. The AIOL comprises a stiff ornon-deflectable member 3310 (e.g., one more convexly curved opticalsurface), a deflectable member 3303 (e.g., an optical material having auniform and constant thickness to inhibit distortion), a fluid-filledchamber 3312, and a lever or cantilevered haptic structure 3302. Thelever structure haptic 3302 is connected to the stiff member 3310 at afirst anchor point 3340 or region, such as a thin portion near an outeredge of the stiff member 3310. The first anchor point 3312 or region maybe any point or region along an axis extending though the outer edge ofthe stiff member 3310 and the perimeter of the lever structure haptic3302. When the AIOL is placed in the lens capsule of the eye, theperimeter of the lever structure haptic 3302 may extend in a directiontransverse or normal to an optical axis of the eye. The lever structurehaptic 3302 is also connected to the deflectable member 3330 through aresilient extension 3311 at a second anchor point 3341 or region. Inmany embodiments, the resilient extension 3311 has a thickness less thanthe thickness of the deflectable member 3303. In these embodiments, thelever structure haptic 3302 has a thickness and a length greater thanthe thickness. The length of lever structure haptic 3302 can be greaterthan the distance between the first anchor point 3340 and second anchorpoint 3341, such that mechanical leverage (e.g., an inward force fromthe lens capsule or pressure of the eye) can be applied to the secondanchor point 3341 from the end of the lever structure haptic 3302contacting the lens capsule of the eye.

In many embodiments, the rotation of lever structure haptic 3302 aboutthe first anchor point 3340 of stiff member 3310 can exert a force onresilient extension 3311 in order to deflect resilient extension 3311and deflectable member 3303 in opposite directions with oppositecurvatures. For example, the rotation may cause resilient extension 3311to move closer to the stiff member 3310 with an outer concave surfaceand deflectable member 3303 to separate further away from the stiffmember 3310 with a convex outer surface. The deflection of deflectablemember 3303 can involve a transition from a first diameter D1 to asecond diameter D2, the second diameter D2 being a smaller than thefirst diameter D1. The decrease in diameter size can cause a convexdeflection 3324 such as a spherical deflection of the deflectable member3303 away from the stiff member 3310. In the deflected configuration3322, the convex deflection 3324 of the deflectable member 3303 can becharacterized by a curvature, and the resilient extension 3311 can becharacterized by an opposite curvature. The curvature of the convexdeflection 3324 can be the opposite of the curvature of the resilientextension 3311. For example, curvature of the convex deflection 3324 maybe a positive along an outer surface of the AIOL and the curvature ofthe extension may comprise a negative curvature along the outer surfaceof the AIOL.

The change in diameter of the deflectable member 3303 from D1 to D2 mayproduce a corresponding amplified movement away from the stiff member3310, such that the deflection height between a first height 3330 and asecond height 3331 is greater than the corresponding change in diameter.In such embodiments, the positive curvature of the spherical deflectioncan cause the fluid-filled chamber 3312 to assume a more convexly curvedprofile to change the optical power of the AIOL. The change in shape ofthe fluid-filled chamber 3312 can cause an increase in volume andthereby pull fluid into the fluid-filled chamber 3312, such as from aperipheral reservoir. Alternatively or in combination, the change inshape of the deflectable member 3303 and fluid chamber 3312 may occurwithout a substantial change in volume of the chamber 3312. For example,the change in the shape of the fluid-filled chamber 3312 can cause aredistribution of the internal fluid to change optical power such as bydrawing fluid from an outer portion of the chamber 3312 and withoutdrawing fluid from a peripheral reservoir. Also, the rotation of thelever structure haptic 3302 may cause the deflectable member 3303 andthe stiff member 3310 to translate together in the anterior directionrelative to the outer edge of the lever structure haptic 3302 when theAIOL is placed in the lens capsule. Such translation may further changethe optical power of the eye. The separation of the deflectable member3303 away from the stiff member 3310, the deflection of the deflectablemember 3303 to increase its curvature, and the translation ofdeflectable member 3303 and the stiff member 3310 together in theanterior direction may combine to change the optical power of the eye.For example, this combination can amplify a small contraction in thelens capsule housing the AIOL into a significant change in optical powerof the AIOL. Such a change in optical power may be significantly greaterthan any of one of separation, deflection, and translation motionsalone.

The haptic structures described herein may comprise of silicones,urethanes, or other suitable thermoplastics, PMMA and PMMA copolymers.In many embodiments, the haptic structures comprise the same or similarmaterials as the optical structure.

FIG. 34A shows an AIOL in accordance with embodiments. As noted herein,the undeflected configuration 3421 is shown in grey and the deflectedconfiguration 3522 is shown with diagonal lines. The AIOL comprises theinner optical portion 3525 and the extension as described herein.Similar structures identified with similar last two digits areidentified herein.

FIG. 34B shows internal pressure of the AIOL chamber as in FIG. 34B. Thepressure of the internal chamber 3412 is shown to increase with load.This increased pressure with load indicates that both the inward forceof the lever haptic structure and internal pressure of the AIOLcontribute to the convex deflection 3424 of the inner optical structure3425.

FIG. 35A shows an AIOL in accordance with embodiments. As noted herein,the undeflected configuration 3521 is shown in grey and the deflectedconfiguration 3522 is shown with diagonal lines. The AIOL comprises theinner optical portion 3525 and the extension as described herein.Similar structures identified with similar last two digits areidentified herein.

FIG. 35B shows internal pressure of the AIOL chamber as in FIG. 35B. Thepressure of the internal chamber 3512 is shown to decrease with load.This decreased pressure with load shows that the inward force of thelever haptic structure is capable of providing the convex deflection3524 of the inner optical structure 3525. Furthermore, as the pressureis negative, this pressure response curve shows that the deflection andchange in optical power are the result of mechanically driven inwardradial loading as opposed to from pressure from the fluid of thechamber. FIG. 35B shows that the inward force of the lever hapticstructure is capable of deflecting deflectable member 2502 with negativepressure of the internal chamber.

Bonding

Bonding can be used to bond one or more of many AIOL structures asdisclosed herein. The structures can be bonded in one or more of manyways as described herein, and the steps, processes and materials can becombined to provide improved bonding of the AIOL structures.

The bonding of components as described herein can be used with one ormore of many IOL components, can be used with one or more of many IOLmaterials, can be used with accommodating and non-accommodating IOLs,and can be used with one or more of many AIOLs as described herein, forexample. The accommodating IOL may comprise one or more haptics tocouple the disc shaped components to the capsular bag in order to changethe optical power of the lens in response to deformations of thecapsular bag. In many embodiments, the one or more haptics comprisechambers fluidically coupled to the chamber comprising the first andsecond lens components. The haptics can be made of a soft material asdescribed herein, such as an acrylate polymer or a silicone polymer, andcombinations thereof, for example.

Although reference is made to bonding stiff, machined polymer, thebonding as disclosed herein can be used with one or more of hydratedpolymer, soft hydrated polymer, machined polymer, molded polymer, moldeddry polymer, molded stiff polymer, molded soft polymer, or moldedhydrated polymer, and combinations thereof, for example.

In many embodiments, the AIOL comprises a first component and a secondcomponent. A first component comprises a first disc shaped structure andthe second component comprises a second disc shaped structure. Anannular structure extends between the first disc shaped structure andthe second disc shaped structure to define a chamber containing a fluidhaving an index of refraction greater than about 1.336, which is theindex of refraction of the aqueous humor of the eye. When one or more ofthe first disk structure or the second disk structure increases incurvature, optical power of the AIOL increases.

The first and second components can be bonded to each other at one ormore bonding surfaces. The location of the bonding surface(s) can beselected to decrease the impact of the bonding surface(s) on the opticalproperties of the AIOL. For example, a bonding surface can extendcircumferentially around one or more of the annular structure, the firstdisc shaped component, the second disc shaped component, andcombinations thereof. In many embodiments, the bonding surface islocated in or near a seam extending circumferentially around the one ormore of the annular structure, the first disc shaped component, thesecond disc shaped component, and combinations thereof, which bonds thecomponents together. Locating the seam away from the optical portions ofthe first and second components provides improved optical properties.

In many embodiments, the first and second components are machined on alathe to provide rotationally symmetric structures, such as the firstdisc shaped structure and the second disc shaped structure. One or moreof the first component or the second component may comprise the annularstructure prior to bonding the components together. One or more annulargrooves can be provided on the first component and the second componentin order to align optically the first component with the secondcomponent. One or more portions of the annular grooves, or other shapedgroove or grooves, can be used as bonding surfaces for bonding the firstand second components together.

Various techniques can be used to bond the first and second componentsto each other. For example, direct bonding methods can be used to jointhe bonding surfaces described herein. Direct bonding methods canadvantageously provide a continuous bonded interface having similarmaterial and mechanical properties as the rest of the structure. Forexample, the bonded interface may swell similarly to the first andsecond components of the structure. Exemplary direct bonding methods mayinclude thermal bonding, solvent bonding, localized welding, or surfacemodification.

Thermal bonding of the first and second components can involve heatingthe components (e.g., at or near the bonding surfaces) to a temperaturenear or above the glass transition temperature of one or both of thecomponents. During the heating process, pressure can be applied toincrease the contact forces between the components at the bondingsurfaces. The use of suitable temperature and pressure conditions cancause the polymer chains of the components to interdiffuse between thebonding surfaces and entangle with each other, thereby bonding the firstand second components together.

Solvent bonding can involve applying a suitable solvent to the bondingsurfaces of the first and second components. The solvent can solvate thepolymer chains of the components at the bonding surfaces, therebyincreasing chain mobility and interdiffusion between the bondingsurfaces. For instance, solvent bonding of components fabricated from acopolymer of HEMA and MMA may be facilitated by treating the bondsurfaces with a suitable solvent. Exemplary solvents can include EGDMA,diethylene glycol dimethacrylate (DEGDMA), triethylene glycoldimethylacrylate (TEGDMA), water, methanol, ethanol, acetone, dimethylsulfoxide, acetonitrile, isopropanol, n-hexanol, ethylene dichloride,methylene dichloride, cyclohexane, or suitable combinations thereof. Thebonding surfaces can be cleaned and then wetted with the solvent. Thebonding surfaces can be brought into contact with each other and bondedby being subjected to suitable pressure and temperature conditions(e.g., using a press, oven, heated plates, etc.) for a predeterminedlength of time.

Localized welding can involve the focused application of energy at ornear the bonding surfaces to heat and soften the bonding surfaces,thereby bonding the components together. Suitable forms of energy mayinclude ultrasonic energy, microwave energy, or infrared energy. In someinstances, suitable components can be formed in one or more of thecomponents so as to direct the applied energy to the appropriate regionsof the bonding surfaces.

As another example, suitable surface modification techniques can beapplied to one or more of the bonding surfaces described herein in orderto achieve direct bonding. Surface modification can involve treating thebonding surfaces in order to increase the surface energies thereof, thusimproving surface contact and increasing the extent of polymer chainentanglement between the bonding surfaces. In many embodiments, thebonding surfaces can be modified by plasma activation, UV exposure,and/or ozone exposure. The parameters of the surface modificationtreatments described herein (e.g., treatment time) can be selected so asto optimize the extent of surface rearrangement of polymer chains at thebonding surfaces.

Alternatively or in addition, indirect bonding techniques utilizingsuitable adhesives can be used to bond first and second components of anAIOL. The adhesive can be applied to at least a portion of the bondingsurfaces described herein. In many embodiments, the adhesive is selectedto have similar material and mechanical properties as the first andsecond components. For example, the adhesive may comprise a prepolymerof the polymer of the components. The prepolymer may comprise one ormore of a monomer, an oligomer, a partially cured monomer, particles, ornanoparticles of the polymer, for example. Such bonding embodiments canprovide advantage in that there is no or a decreased seam—the bondedinterface has similar mechanical properties as the structure. Forexample, the adhesive may swell similarly to the first and secondcomponents. This can be helpful when the adhesive is providedcircumferentially around the first and second components as describedabove, as such components can swell substantially along the diameter andcircumference, for example. Decreasing stresses along the bondingsurfaces of an AIOL can be helpful, as the AIOL can be made smaller todecrease insertion size and may comprise thin deformable structuresconfigured to deform with decreased stresses.

In many embodiments, the adhesive (e.g., the prepolymer) is cured tobond the first and second components together. The curing process mayinvolve the polymerization of one or more constituents of the adhesiveusing techniques known to one of skill in the art. For example,precursor monomers in a prepolymer may be partially or fully polymerizedby the addition of an initiator. The initiator may be a photoinitiatorsuch as Irgacure 651 (I651, Ciba-Geigy), or a radical initiator such as2,2′-azobis(isobutyronitrile), 2,2′-azobis(2,4-dimethylvaleronitrile),dilauroyl peroxide, or bis(4-t-butylcyclohexyl)peroxydicarbonate, forexample. In many embodiments, the monomers are polymerized in thepresence of a crosslinking agent. The crosslinking agent may compriseone or more of EGDMA, DEGDMA, or TEGDMA. The polymerization of themonomers and crosslinking agent may form an interpenetrating polymernetwork (IPN), which may be entangled with the first and secondcomponents, thereby joining them together. In some instances, thebonding surfaces can be activated using suitable activating agents toprovide exposed reactive groups, thereby enabling the formation ofchemical bonds between the bonding surfaces and the prepolymer and/orcrosslinking agent. Following the polymerization process, excessreagents can be removed by rinsing, immersion in a suitable solvent, orother methods known to those of ordinary skill in the art.

The bonding techniques described herein can be applied at any pointduring the fabrication of the AIOLs described herein. For example, thefirst and second components can be bonded to each other while in thestiff, substantially dry configuration. Each of the components can beprovided in a stiff configuration for machining and bonded together withthe adhesive while in a stiff configuration. The components can besubsequently hydrated. Alternatively, the components can be bonded whilein a partially or fully hydrated configuration.

In many embodiments, the first and second lens components comprise acopolymer of hydroxyethyl methacrylate and methyl methacrylate. Whencured, the adhesive comprises the copolymer of hydroxyethyl methacrylateand methyl methacrylate. This configuration can allow the lens to expandfrom a stiff less than fully hydrated configuration, to the fullyhydrated configuration with substantially swelling and inhibited stressto the components and the adhesive located along the seam. The stiff,less than fully hydrated configuration of the polymer material will beunderstood by a person of ordinary skill in the art to comprise apolymer having a sufficiently low amount of water to provide stiffnessto the polymer material of the first and second components. The lessthan fully hydrated configuration may comprise a substantially dryconfiguration composed of no more than about 5% water, for example0.2-3% water, such that the polymer material comprises sufficientstiffness for machining the material to optical tolerances as will bereadily understood by a person of ordinary skill in the art. When theAIOL is placed in the lens capsule or placed in a hydration buffer asunderstood by a person of ordinary skill in the art, for example, thepolymer may swell to a hydrated state and gradually to a fully hydratedstate. The polymer in the fully hydrated state may be composed of about15% to 30% water, for example, depending on the material selected. Thepolymer in the fully hydrated state may swell by more than 10%, such as10% to 15%.

FIG. 36 shows a method 3600 of manufacturing and providing an AIOL.

At a step 3610, a block of polymer material as described herein isprovided. The block of material is cut into a first component 3612 and asecond component 3614. The polymer material comprises a stiffconfiguration as described herein.

At a step 3620, the first component 3612 and the second component 3614are shaped into first lens component 3622 and second lens component 3624of the AIOL. The components can be shaped in one or more of many wayssuch as turning on a lathe, cutting, ablation, and other known methodsof shaping optical lenses. Alternatively or in combination, thecomponents may be molded. One or more of the components 3622, 3624comprises a feature 3626 shaped to receive the opposing component (thefeature 3626 may comprise an annular groove, for example). A channel3628 can be provided to allow fluidic communication with the chamber3636 of the AIOL. Alternatively or in combination, the channel 3628 canbe formed when the first and second components are bonded together.

At a step 3630, the first and second components 3622, 3624 are bondedtogether with an adhesive 3632 provided in the feature 3626. The firstcomponent 3622 and the second component 3624 define a chamber 3636.

The adhesive 3632 comprises a prepolymer of the polymer of thecomponents 3612 and 3614. Although the components are shown providedfrom a single block, the polymer material can be provided with separateblocks of material having similar polymer composition.

A haptic 3638 can be affixed to the AIOL 3635, such that an internalchamber of the IOL is fluidically coupled to the chamber of the haptic.The haptic may comprise a material similar to the AIOL, or a differentmaterial. The haptic 3638 may have a thickness 3639. For example, theAIOL may comprise an acrylate as described herein and the haptic 3638may comprise a soft silicon material. The haptic may comprise a softmaterial inserted into the AIOL when the AIOL comprises a stiffconfiguration, for example.

The AIOL in the stiff configuration comprises a dimension 3634 across,such as a diameter. The AIOL may comprise a thickness 3648 extendingbetween an anterior most portion of the AIOL body and the posterior mostportion of the AIOL body.

At a step 3640, the AIOL 3635 is hydrated to a substantially hydratedconfiguration to decrease stiffness, such that the AIOL comprises a softmaterial. In the hydrated configuration dimensions of the AIOL increase,and may increase proportionally to each other. In many embodiments, theincrease comprises a similar percentage increase along each dimension.

In many embodiments, the amount of hydration in the stiff configurationcomprises a predetermined amount of hydration in order to accuratelymachine the lens components to an appropriate amount of refractive powerwhen the AIOL comprises the fully hydrated state when implanted in theeye.

The disc shaped optical structure of the upper component 3622 can beflat, or lens shaped, for example. The disc shaped optical structure ofthe lower component 3622 can be flat, or lens shaped, for example, suchthat one or more of the optical structures deforms to provide opticalpower.

FIG. 37 shows the optical structure deformed with a deflected surfaceprofile in order to provide optical power with a curved sphericalsurface profile 3700 as described herein. The fluid of the AIOL can begreater than the index of refraction of 1.33 of the aqueous humor inorder to provide the increased optical power with curved surface 3700.The optical component 3624 may comprise a substantially planar shapeproviding no significant optical power in a first configuration, and canbe deformed to a deflected curved spherical surface profile 3700 thatprovides optical power for accommodation.

While reference is made to acrylates, the polymer and prepolymer maycomprise silicone hydrogel materials, for example.

FIG. 38A shows an AIOL with an anterior-most portion of the AIOLanterior to the anterior most-portion of the haptic (both shown lower onthe page), in which the deflectable member of the AIOL is configured todeflect in response to translational and rotational movement of thehaptic. In alternative embodiments, the lens can be placed with anopposite anterior posterior orientation as described herein. Thedeflectable member 3803 comprises sufficient radial strength such that aradially inward force to an outer portion of the deflectable membercauses deflection of an inner portion of the deflectable member asdescribed herein.

The deflectable member can be configured in one or more of many ways toprovide radial strength in order deflect to at least the inner portion,for example with one or more of a modulus of elasticity, a thickness, ora diameter.

The deflectable member can be coupled to the haptics in one or more ofmany ways so as to deflect when urged radially inward by the hapticsengaging the lens capsule. In many embodiments, the deflectable membercomprises sufficient radial strength to induce shape changes of at leastthe inner portion when the outer portion of the deflectable member isurged radially inward, or rotated, and combinations thereof. In manyembodiments, the deflectable member is coupled to the lens capsule suchthat rotation of the haptics relative to the stiff member induces aradially inward movement and rotational deflection of an outer portionof the deflectable member. Alternatively or in combination, the hapticscan be arranged to slide radially and in relation to the stiff member inorder to urge the deflectable member inward with radial force anddeflect the inner portion of the deflectable member with radial strengthof the outer portion. The deflectable member may comprise one or morestructures on the outer portion to encourage deflection, such as aconcave outer portion or thinner annular region to encourage concavedeflection of the outer portion and convex deflection of the innerportion, for example.

The AIOL comprises undeflected configuration 3821 for far vision anddeflected configuration 3822 for near vision. The AIOL is depicted in anon-accommodating configuration with a planar configuration anteriorplanar deflectable member 3803 coupled to lever haptic structure 3802.An outer structure of haptic 3802 is configured to engage the lenscapsule, and may comprise structures to reduce pressure on the capsuleas described herein. A stiff member 3810 may comprise a lens to provideoptical power for far vision. The deflectable member 3803 may comprise asubstantially planar member having a substantially constant thickness,for example. The deflectable member 3803 comprises an inner opticalportion 3825 and an extension 3811. Extension 3811 extends between theinner optical portion 3825 and the translating and rotating hapticstructure 3802. When the inner optical portion 3825 comprises the convexdeflection 3824, the fluid of the chamber beneath the inner opticalportion is shaped to provide an optical correction for near vision.

The deflectable member 3803 and stiff member 3810 define at least aportion of an inner chamber 3812 as described herein.

The AIOL comprises a central thickness extending from an outer surfaceof the stiff member 3810 to an outer surface of the deflectable member3803. The central thickness may comprise a first central thickness 3830of the lens in a far vision configuration, and a second centralthickness 3831 of the lens in a near vision configuration. The increasein thickness of the lens centrally is related to the increased opticalpower of the lens. The increased optical power of the lens is alsoapproximately inversely related to a square of the diameter of thecentral optical portion. The extension portion can decrease the diameterof the optical portion and provide increased optical power for an amountof change between first distance 3830 and second distance 3831.

The stiff member 3810 is connected to haptic structure 3802, such thatthe haptic structure 3802 rotates when the lens accommodates for nearvision. The haptic structure 3802 extends to a first anchor region suchas an anchor point 3840 about which the haptic translates and rotatesrelative to the stiff member 3810. The haptic structure extends adistance from the first anchor region to the wall of the lens capsule.The haptic structure 3802 extends to a second anchor region such assecond anchor point 3841. The second anchor region 3841 couples to thedeflectable member 3803 in order to induce inward force on thedeflectable member. The distance from the first region to the outerstructure of the haptic engaging the lens capsule is greater than thedistance from the first region to the second region. In at least someembodiments, this difference in distance can provide at least somemechanical leverage of the lens capsule forces on the deflectable member3803. The radial force of the lens capsule on the deflectable member3802 induces a convex deflection 3824 of the deflectable membrane. Theextension 3811 comprises an opposite concave curvature.

The components of the AIOL such as the stiff member, the deflectablemember, and the one or more haptics may comprise the same polymer asdescribed herein. These components can have varying amounts of softnessand stiffness depending on the thickness, for example. In manyembodiments the haptic comprises a thickness to as reversibly deform atleast partially when urging the deflectable member radially inward withone or more of rotation or translation in response to radially inwardforce from the lens capsule.

FIG. 38B shows internal chamber pressure in response to loading of theAIOL as in FIG. 38A. The internal pressure of the AIOL increasesapproximately linearly with the load of the AIOL. The combination ofinternal pressure and radially inward force can deflect the member 3803to provide optical power when the eye accommodates as described herein.The load modeled was normalized with respect to one or more publishedmaximum load values corresponding to force of lens capsule on the AIOL,which can be readily determined by a person of ordinary skill in the artbased on published data. The material properties of the AIOL as modeledherein can be readily determined based on published data for thematerials as described herein.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the disclosure describedherein may be employed in practicing the disclosure. It is intended thatthe following claims define the scope of invention and that methods andstructures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An accommodating intraocular lens, comprising: afirst component having a first optical structure and a first hapticreservoir portion, and the first optical structure being fixed at onlyits periphery; a second component having a second optical structure anda second haptic reservoir portion, the second optical structure beingfixed at only its periphery, and the second component being attached tothe first component such that (a) the first optical structure is alignedwith the second optical structure to form a fluid chamber between thefirst and the second optical structures that defines an optical elementand (b) the first haptic reservoir portion is aligned with the secondhaptic reservoir portion to define a fluid reservoir having a deformableouter wall configured to engage a native capsule of an eye; and an innerwall comprising a portion of at least one of the first component and thesecond component and extending between and separating the fluid chamberand the fluid reservoir, the inner wall comprising one or more openings;wherein the fluid reservoir is fluidically coupled to the fluid chambersuch that deformation of the outer wall causes fluid to flow through theone or more openings between the fluid reservoir and the fluid chamber;and wherein a center region of the first optical structure is free tomove under forces of a native eye capsule with respect to the secondoptical structure along a central anterior-posterior axis of theaccommodating intraocular lens.
 2. The accommodating intraocular lens asin claim 1, wherein: the first component comprises a polymer material;the second component comprises the polymer material of the firstcomponent; and the first and the second components are attached to eachother with an adhesive at a seam between the first haptic reservoirportion and the second haptic reservoir portion, and the adhesivecomprises a pre-polymer of the polymer material of the first and thesecond lens components.
 3. The accommodating intraocular lens as inclaim 2, wherein the intraocular lens comprises a stiff configurationprior to implantation and a soft configuration when implanted andwherein the intraocular lens comprises the soft configuration whenhydrated and each of the first component, the second component and acured adhesive expand a substantially similar amount from the stiffconfiguration to the soft configuration thereby inhibiting stress atinterfaces between the cured adhesive and the first and the secondcomponents.
 4. The accommodating intraocular lens as in claim 2, whereinthe pre-polymer is selected from ethylene glycol dimethacrylate (EGDMA),diethylene glycol dimethacrylate (DEGDMA), triethylene glycoltrimethacrylate (TEGDMA), hydroxyethyl methacrylate (HEMA), and methylmethacrylate (MMA).
 5. The accommodating intraocular lens as in claim 2,wherein the adhesive comprises a monomer, an oligomer, a partially curedmonomer, particles, or nanoparticles of the polymer material.
 6. Theaccommodating intraocular lens as in claim 1, further comprising a fluidwithin the chamber having an index of refraction greater thanapproximately 1.336 and wherein one or more of the first component orthe second component is configured to deform to increase an opticalpower of the accommodating intraocular lens.
 7. The accommodatingintraocular lens as in claim 1, wherein the outer wall of the fluidreservoir is configured to engage a wall of the native capsule of theeye and increase curvature of one or more of the first optical structureor the second optical structure in response to the wall of the capsularbag contracting and thereby increase optical power of the accommodatingintraocular lens.
 8. The accommodating intraocular lens as in claim 1,further comprising a fluid in the fluid reservoir and the chamber, thefluid comprising one or more of a solution, an oil, a silicone, asilicone oil, a solution of high molecular weight molecules or highmolecular weight dextran.
 9. The accommodating intraocular lens as inclaim 1, the seam extends continuously circumferentially around thefluid reservoir.
 10. The accommodating intraocular lens as in claim 1,wherein the first optical structure comprises a first disc shapedoptical structure comprising one or more of a lens, a meniscus, ameniscus lens, or a flat plate, and wherein the second optical structurecomprises a second disc shaped optical structure comprising one or moreof a lens, a meniscus, a meniscus lens, or a flat plate.
 11. Theaccommodating intraocular lens as in claim 1, wherein the firstcomponent and the second component are of the same polymer material. 12.The accommodating intraocular lens as in claim 1, wherein a change inoptical power of the accommodating intraocular lens comprises a responseto a transfer of fluid into or out of the chamber from the fluidreservoir defined between the first and the second lens components. 13.The accommodating intraocular lens as in claim 1, wherein water presentin the lens capsule of the native capsule of the eye transfers into orout of the chamber through a polymeric material of the first and thesecond lens components to achieve an osmotic equilibrium with fluidpresent in the lens capsule when the intraocular lens is placed therein.14. The accommodating intraocular lens as in claim 1, wherein theintraocular lens is configured to be folded into a reduced cross-sectiondelivery configuration; wherein the reduced cross-section deliveryconfiguration of the intraocular lens is attained by folding or rollingthe intraocular lens around a delivery axis normal to the centralanterior-posterior axis of the intraocular lens; and wherein the reducedcross-section delivery configuration of the intraocular lens is attainedby advancing the intraocular lens through a delivery tube or aperture.15. The accommodating intraocular lens as in claim 1, wherein the firstoptical structure comprises a first lens, the second optical structurecomprises a second lens, and a center region of the first lens is freeto move with respect to the second lens along the centralanterior-posterior axis of the accommodating intraocular lens.
 16. Theaccommodating intraocular structure of claim 15, wherein the first andthe second lenses comprise first and second membranes, respectively. 17.The accommodating intraocular lens as in claim 1, wherein the first andthe second optical structures are configured such that maximumdisplacement between the first and the second optical structures occursalong the central anterior-posterior optical axis of the accommodatingintraocular lens.
 18. The accommodating intraocular lens as in claim 1,further comprising spacers spaced apart from each othercircumferentially around the first and the second optical structures.19. The accommodating intraocular lens as in claim 1, wherein in theoptical structures are adhered to each other at only their peripheries.20. An accommodating intraocular lens, comprising: a first componenthaving a first optical structure and a first haptic reservoir portion;and a second component having a second optical structure and a secondhaptic reservoir portion, the second component being attached to thefirst component such that (a) the first optical structure is alignedwith the second optical structure to form a fluid chamber between thefirst and the second optical structures that defines an optical element,(b) the first haptic reservoir portion is aligned with the second hapticreservoir portion to define a fluid reservoir having a deformable outerwall configured to engage a native capsule of an eye, and (c) an innerwall of the fluid reservoir is formed by one or both of the firstcomponent and the second component to separate the fluid chamber fromthe haptic reservoir, wherein the first and the second opticalstructures are configured such that maximum displacement between thefirst and the second optical structures occurs along a centralanterior-posterior optical axis of the accommodating intraocular lens;the fluid reservoir is fluidically coupled to the fluid chamber suchthat deformation of the outer wall causes fluid to flow through theinner wall between the fluid reservoir and the fluid chamber.